Events
The Navitas Life Sciences team are delighted to be a sponsor at the SCDM Global Conference which is themed around Future Now: v2.021.
The Navitas Life Sciences team are delighted to be a sponsor at the SCDM Global Conference which is themed around Future Now: v2.021.
We look forward to meeting with you at our virtual exhibition booth where we can discuss how we can support you with data driven, patient centric, and efficient trials to help speed your product to market. If you would like to meet with our subject matter experts please click here to schedule a meeting.
For further information about the conference, please visit the event website at: https://scdm2021.org/
Join our latest webinar, Enhance your Data Science toolkit...
Join our latest webinar, Enhance your Data Science toolkit with open source tools, as our subject matter experts explore how R can create efficiencies in data review and insight.
The webinar will explore the following key topics:
- Alternative solutions to unlocking valuable insights from rich and diverse data
- Statistics, Analytics, and Visualization – complementing the use of SAS with R
- Ensuring regulatory compliance when using open source software
- A robust Risk Assessment Framework
- Validation
- Documentation
- Industry innovation and collaboration to develop better technology ecosystems
Speakers
Shrishaila Patil
Vice President, Statistical Programming
Navitas Data Sciences
Troy Ruth
Director, Clinical Reporting
Navitas Data Sciences
To register for this webinar, please click here
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.
This roundtable meeting will explore Governance of Digital Health Platforms – with a spotlight on COVID-19 as an accelerator, strategies to building capability, and Health Authority expectations and impact.
Please be advised that this is an invitation only event.
For further information please contact us at cmonet@navitaslifesciences.com
Navitas Data Sciences are pleased to be a Ruby Sponsor at the CDISC 2021 US Interchange.
Navitas Data Sciences are pleased to be a Ruby Sponsor at the CDISC 2021 US Interchange.
Navitas Data Sciences is the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences and has global solutions for all your biostatistics, statistical programming, and data management needs.
If you would like to arrange to meet with our team of experts, either virtually or onsite at the event, and learn how we can help you to meet the future challenges of Data requirements in your clinical trials, please click here.
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in 2016
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in 2016, pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
We are delighted to be hosting our 11th forum this autumn. The agenda for the event is themed around the Evolution of the PV Ecosystem and will focus on the following:
- Navigating the Global/Local QPPV Landscape
- Next Generation Safety Systems
- Post Pandemic Strategies
For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range...
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect Autumn agenda for day one is themed Collaborate beyond Compliance and will focus on the following:
- Regulatory Intelligence – what does good look like?
- FDA IND Submissions – overcoming challenges
- Gaining efficiencies in PV agreements
- Cross-functional safety – best practices working with clinical and quality
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet Autumn agenda for day one is themed around Fueling Innovation – Digital and Beyond and will focus on the following:
- Digital and automation – powering the future of labeling
- Real World Data and beyond – building data capabilities
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech Autumn agenda is themed around Digital PV Tools – a Tech Showcase and will focus on the following:
- AI enabled ICSR Automation/Alternative SDB
- Modern safety science systems
- Tools for efficiency: Ancillary activities (Inspections, PVA, AI, enabled literature, etc.)
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet Autumn agenda for day one is themed around PV success stories – Collaborate, Co-Create, and Co-Innovate and will focus on the following:
- Inspections and cross-functional collaborations
- Navigating the Global – EU – Local QPPV Networks
- Gaining efficiencies in PV agreements
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect Autumn agenda for day one is themed around Quality Management – the simpler the better and will focus on the following:
- Leveraging Quality Management and Compliance for efficiency
- Process and document simplification – the art of the possible
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range...
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect Autumn agenda for day two is themed around Starting small and seeing success and will focus on the following:
- The latest RPA use cases
- Spotlight on signal detection
- Innovation in the PSMF
- Social media – scope for change?
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet Autumn agenda for day two is themed around Accelerated Labeling – the new normal? and will focus on the following:
- Target labeling – defining what good looks like
- Accelerated submissions – readying labeling for competitive advantage?
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management
The rimnet Autumn agenda for day one is themed around Driving innovation in challenging times and will focus on the value of RIM as an integral business driver, delivering ROI from RIM, and the RIM Maturity Model.
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech Autumn agenda is themed around Digital PV Tools – a Tech Showcase and will focus on the following:
- AI enabled ICSR Automation/Alternative SDB
- Modern safety science systems
- Tools for efficiency: Ancillary activities (Inspections, PVA, AI, enabled literature, etc.)
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet Autumn agenda for day two continues the theme PV Success Stories – Collaborate, Co-Create, and Co-Innovate and will focus on the following:
- Reimaging safety science organizations – enhancing efficiency, creating value
- Exploring the expanded PV eco-system – Epidemiology, Clinical Safety
- Innovations in signal and risk management
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect Autumn agenda for day two is themed around Labeling Tracking – Start, Stop, Reset and will focus on the following:
- Day 0 and tracking
- Categories and timelines – evolution and where next?
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management
The rimnet Autumn agenda for day two is themed around RIM in Action – where next? This session will focus on building out the vision for RIM in 2025, the roadmap to get there, as well as looking at the challenges.
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.
This roundtable meeting will explore Medical Affairs of the Future – with a spotlight on the use of social media, the value proposition and metrics, and the diversity of investigators and data collection.
Please be advised that this is an invitation only event.
For further information please contact us at cmonet@navitaslifesciences.com
Join our subject matter expert, Dr. Latika Sharma, PV Networks Lead at Navitas Life Sciences for our live webinar Shifting Sands of Pharmacovigilance – Pivot, Maneuver, Breakout as she explores the following key themes:
Join our subject matter expert, Dr. Latika Sharma, PV Networks Lead at Navitas Life Sciences for our live webinar Shifting Sands of Pharmacovigilance – Pivot, Maneuver, Breakout as she explores the following key themes:
- Macro shifts shaping the future course of PV
- Industry’s response – data, digital, and skills
- What might PV in 2030 look like?
To register for this webinar, please click here
IDMP is fast becoming a reality. Join subject matter experts, Gary Wilson, Director at CorrIT and Raj Srinivasan,
IDMP is fast becoming a reality. Join subject matter experts, Gary Wilson, Director at CorrIT and Raj Srinivasan, Executive Business Partner - Safety and Regulatory Technology – EMEA & APAC at Navitas Life Sciences for our live webinar as we explore the following key themes:
- The IDMP countdown has started
- Opportunities for Enhancing Regulatory Information Management
- A global approach to Regulatory compliance with associated guidance and timelines
- Technology that supports RIM and Harmonization of Global/Local Term Stores
To register for this webinar, please click here
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management
The rimnet Spring agenda is themed around Delivering Value through Driving Best Practices and will focus on:
- rimnet – where next on the journey?
- Putting it into action: RIM vision for 2025
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
labeltech is a network for Regulatory and IT professionals; focused on exploring end-to-end labeling technologies to improve processes
labeltech is a network for Regulatory and IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.
The labeltech Spring agenda is themed around Structured Content – The Future of Labeling Authoring and will focus on the following:
- The what and why of Structured Content Authoring
- The current state of play and industry landscape
- A showcase of emerging tools and solutions
For further information, or to register your interest, please contact us at labeltech@navitaslifesciences.com
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect Spring agenda is themed around Operations and Compliance – Global Connections and Inspection Readiness and will focus on the following:
- End-to-End Labeling – Affiliate Spotlight, Operational Model/Sourcing, Alignment
- Inspection Readiness in a post-COVID world
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet Spring agenda is themed around PV2025 - 360° Global PV Transformation and will focus on the following:
- Using regulations to inspire quality
- Building a learning PV Organization
- Innovations in Risk minimization design & evaluation
- Data Science-The insights machine
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management
The rimnet Spring agenda is themed around Delivering Value through Driving Best Practices and will focus on:
- rimnet – where next on the journey?
- Putting it into action: RIM vision for 2025
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech Spring agenda is themed around PV2025 and Technology – Tools, Data, and Digital for End-to-End Safety and will focus on the following:
- PV Systems for Efficiencies and Insights
- Data and Analytics Strategy in PV
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet Spring agenda is themed around Future Labeling – Deliver Today and Get Future Ready and will focus on the following:
- Workforce of the Future – Leadership, Sourcing, COVID-19 impact
- Target Labeling – Where Next? How to Accelerate, and the Role of Real World Data (RWD)
- Digital delivering End-to-End Value – 2025 roadmap, patient focus
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect Spring agenda is themed around Global Governance and Digital Decisions and will focus on the following:
- Affiliate Governance and Oversight
- PV Workforce – Sourcing and Talent
- Efficiency in Signal Detection
- Digital PV – AI in action
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
The Navitas Data Sciences team are delighted to be a media sponsor at PHUSE Virtual US Connect 2021 – The Clinical Data Science Conference
The Navitas Data Sciences team are delighted to be a media sponsor at PHUSE Virtual US Connect 2021 – The Clinical Data Science Conference
Navitas Data Sciences is the global Functional Service Provider (FSP) division of Navitas Life Sciences providing highly skilled Data Manager, Statistical Programmers, and Biostatisticians for all your Biostatistics, Statistical Programming, and Data Management Needs.
For further information about the conference, please visit the event website at: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=2283&eventID=6
Navitas Data Sciences are pleased to be presenting at the upcoming PHUSE India Summer Single Day event.
Navitas Data Sciences are pleased to be presenting at the upcoming PHUSE India Summer Single Day event. Our expert and Principal SAS Programmer, Mr Sasidhar Amilineni will be presenting a session between 12:30 and 13:00 IST on Real World Data/Real World Evidence providing an introduction as well as the associated challenges and best practices from a programmer’s perspective.
If you would like to arrange to speak with Sasidhar and learn how we can help you meet the future challenges of data requirements in your clinical trials then please click here
For further information please visit the event website: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=2841&ef_sel_menu=251&eventID=7
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect Spring agenda is themed around Operations and Compliance – Global Connections and Inspection Readiness and will focus on the following:
- End-to-End Labeling – Affiliate Spotlight, Operational Model/Sourcing, Alignment
- Inspection Readiness in a post-COVID world
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet Spring agenda is themed around PV2025 - 360° Global PV Transformation and will focus on the following:
- Using regulations to inspire quality
- Building a learning PV Organization
- Innovations in Risk minimization design & evaluation
- Data Science-The insights machine
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
labeltech is a network for Regulatory and IT professionals; focused on exploring end-to-end labeling technologies to improve processes
labeltech is a network for Regulatory and IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.
The labeltech Spring agenda is themed around Structured Content – The Future of Labeling Authoring and will focus on the following:
- The what and why of Structured Content Authoring
- The current state of play and industry landscape
- A showcase of emerging tools and solutions
For further information, or to register your interest, please contact us at labeltech@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech Spring agenda is themed around PV2025 and Technology – Tools, Data, and Digital for End-to-End Safety and will focus on the following:
- PV Systems for Efficiencies and Insights
- Data and Analytics Strategy in PV
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet Spring agenda is themed around Future Labeling – Deliver Today and Get Future Ready and will focus on the following:
- Workforce of the Future – Leadership, Sourcing, COVID-19 impact
- Target Labeling – Where Next? How to Accelerate, and the Role of Real World Data (RWD)
- Digital delivering End-to-End Value – 2025 roadmap, patient focus
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect Spring agenda is themed around Global Governance and Digital Decisions and will focus on the following:
- Affiliate Governance and Oversight
- PV Workforce – Sourcing and Talent
- Efficiency in Signal Detection
- Digital PV – AI in action
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
Navitas Clinical Research are delighted to be attending and exhibiting at the upcoming Outsourcing in Clinical Trials East Coast 2021 event.
Navitas Clinical Research are delighted to be attending and exhibiting at the upcoming Outsourcing in Clinical Trials East Coast 2021 event. The event aims to explore effective strategies for outsourcing clinical trial operations to ensure that studies run smoothly and within budget.
If you would like to meet with our subject matter experts and learn how you can gain a competitive edge throughout your clinical development process then please click here to arrange a meeting.
For further information please visit the event website: https://www.arena-international.com/octeastcoast/
The Navitas Data Sciences team are delighted to be a Platinum Sponsor at the upcoming PharmaSUG US 2021 event.
The Navitas Data Sciences team are delighted to be a Platinum Sponsor at the upcoming PharmaSUG US 2021 event. We look forward to meeting you at virtual exhibition booth where we are happy to discuss how our reliable statistical programmers can provide key data insights to power better decisions and drive successful outcomes for your organization.
Navitas Data Sciences is the global Functional Service Provider (FSP) division of Navitas Life Sciences providing highly skilled Data Manager, Statistical Programmers, and Biostatisticians for all your Biostatistics, Statistical Programming, and Data Management Needs.
For further information about the conference, please visit the event website at: https://www.pharmasug.org/us/index.html
Navitas Life Sciences is proud to be a Gold Sponsor at the Oracle Health Sciences – India event.
Navitas Life Sciences is proud to be a Gold Sponsor at the Oracle Health Sciences – India event.
With over 50 Argus projects across the globe, we are proud to have been an Oracle Gold partner for over 10 years. Visit our booth to learn how we can help you transform your Pharmacovigilance efforts to deliver maximum value.
For further information about the event or to register please visit: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/
With the ever-increasing need to be compliant as well as audit ready, pharma companies are aspiring to automate and transform their QMS while,
With the ever-increasing need to be compliant as well as audit ready, pharma companies are aspiring to automate and transform their QMS while, at the same time, taking advantage of the latest quality management technology and best practices.
We are delighted to be hosting a webinar with our client Natco Pharma and our partner Sparta Systems. Presented by R. Sridhar Reddy, Vice President – QA, Natco Pharma, this webinar will explore:
- Key industry trends and operational challenges impacting the Pharmaceutical industry
- Best practices for building a successful QMS business case and ensuring project success
- How Natco Pharma transformed their quality management operations by implementing TrackWise QMS
To register for this webinar please click here.
We are delighted to be presenting at the upcoming Uppsala Monitoring Centre WHODrug Webinar on Drug Data Coding Conventions.
We are delighted to be presenting at the upcoming Uppsala Monitoring Centre WHODrug Webinar on Drug Data Coding Conventions. Our Clinical Data Co-ordinator II, Imtiayaz Khan, will deliver a presentation on Drug Data Coding Conventions, exploring processes and also providing an interactive session on the challenges in drug coding.
For further information about the event or to register please visit: https://www.who-umc.org/whodrug/training/webinars/
Navitas Life Sciences is proud to be a Gold Sponsor at the Oracle Health Sciences – Europe event.
Navitas Life Sciences is proud to be a Gold Sponsor at the Oracle Health Sciences – Europe event.
With over 50 Argus projects across the globe, we are proud to have been an Oracle Gold partner for over 10 years. Visit our booth to learn how we can help you transform your Pharmacovigilance efforts to deliver maximum value.
For further information about the event or to register please visit: https://www.oracle.com/uk/industries/life-sciences/health-sciences-connect/sessions/
Navitas Life Sciences is proud to be a Gold Sponsor for the Oracle Health Sciences Connect event.
Navitas Life Sciences is proud to be a Gold Sponsor for the Oracle Health Sciences Connect event.
With over 50 Argus projects across the globe, Navitas Life Sciences is proud to have been an Oracle Gold Partner for over 10 years. Visit our booth to learn about how we can help transform your Pharmacovigilance efforts to deliver maximum value.
Click here to Learn more about the event and to Register
Navitas Data Sciences are pleased to be presenting at the upcoming PHUSE India Spring Single Day Event. Our expert, Shrishaila Patil,
Navitas Data Sciences are pleased to be presenting at the upcoming PHUSE India Spring Single Day Event. Our expert, Shrishaila Patil, Vice President of Statistical Programming, will be presenting a session titled Clinical Data Standards in the era of Artificial Intelligence, Machine Learning, and Digital Transformation between 12:30 and 13:00 IST. The session will explore the following:
- Motivation - The Need of the Hour
- COVID-19 and the wave of Digital Transformation
- Why Data Standards?
- CDISC
- The Road Ahead
- Key Takeaways
If you would like to arrange to speak with Shrishaila and learn how we can help you meet the future challenges of data requirements in your clinical trials, then please click here
For further information or to register to attend, please visit the event website at: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=2841&ef_sel_menu=251&eventID=7
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios.
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
We are delighted to be hosting our 10th forum this Spring. The agenda for this event is themed around Optimizing PV in a Post-Pandemic World and will focus on the following:
- Industry context
- Reflections on current Regulatory landscape
- PV Workforce of the Future
For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com
Navitas Data Sciences are pleased to be presenting at the upcoming CDISC webinar ‘Current and Forthcoming ADaM Publications’. Our expert, Luke Reinbolt,...
Navitas Data Sciences are pleased to be presenting at the upcoming CDISC webinar ‘Current and Forthcoming ADaM Publications’. Our expert, Luke Reinbolt, Lead Consultant and Clinical SAS Programmer Analyst will be presenting on ADNCA.
As the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences, Navitas Data Sciences is a CDISC Registered Solutions Provider and Platinum Member delivering high quality data while ensuring regulatory compliance.
For further information or to register to attend, please visit the event website at: https://www.cdisc.org/events/education/webinars/2021/03/current-and-forthcoming-adam-publications
Navitas Clinical Research are delighted to be participating at the upcoming BioCapital Life Sciences Virtual Career Fair.
Navitas Clinical Research are delighted to be participating at the upcoming BioCapital Life Sciences Virtual Career Fair. We look forward to discussing the open opportunities that we have available
For further information or to register to attend, please visit the event website at: https://mdls.vfairs.com/
Navitas Life Sciences are pleased to be participating at the DIA Regulatory Submissions, Information, and Document Management Forum.
Navitas Life Sciences are pleased to be participating at the DIA Regulatory Submissions, Information, and Document Management Forum. The event brings together industry and regulatory stakeholders working across the scope of regulatory information to examine current data standards and requirements and effective regulatory information management approaches to align related systems. The forum will address four tracks: Regulatory Informatics Business, Regulatory Informatics Technology, Electronic Document Management, and Electronic Regulatory Submissions.
Our subject matter expert, Tris Nockles, will be presenting as part of Track 1: IRISS Forum Hot Topics on 10 February between 16:15 and 17:15 EST. Her session will explore the Electronic Product Information Topic Group Highlights.
If you would like to discuss Tris’ session in more detail, then please complete the form available here.
For further information, please visit the event website: https://www.diaglobal.org/en/conference-listing/meetings/2021/02/regulatory-submissions-information-and-document-management-forum#showcontent
Navitas Life Sciences are delighted to be taking part in the BIO Partnering at JPM event.
Navitas Life Sciences are delighted to be taking part in the BIO Partnering at JPM event.
If you are attending the event and would like to schedule a meeting with our team of experts to learn how we can help you to improve your clinical trial outcomes, please click here.
For further information about the event, please visit the official website at: https://www.bio.org/events/bio-partnering-jpm
Navitas Data Sciences are delighted to be chairing a session at the upcoming SCDM India 2020 virtual event.
Navitas Data Sciences are delighted to be chairing a session at the upcoming SCDM India 2020 virtual event.
Our subject matter expert, Shrishaila Patil, Vice President of Statistical Programming, will be chairing the Track 3 Session titled SDTM and CDASH – Do we need both data standards? on Friday 04 December, 2020 between 14:00 and 15:30 IST.
If you would like to arrange to speak with Shrishaila and learn how we can help you to meet the future challenges of data requirements in your clinical trials, then please click here.
For further information, please visit the event website at: https://scdmindia.org/index.php
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
The rimnet Autumn agenda is themed around ‘Leveraging initiatives and new technology for the RIM roadmap’ and will focus on:
- Regulatory Context
- Industry Context and the RIM Data Model
- RIM Data Governance: Business Drivers for RIM Imperatives
- Advanced Technology in Action
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
labeltech is a network for Regulatory and Labeling IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
labeltech is a network for Regulatory and Labeling IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.
The labeltech Autumn agenda is themed around ‘Integrating Technology into the End-to-End Labeling Process’ and will focus on:
- Building an End-to-End Labeling Technology Roadmap
- Structured Content Authoring
For further information, or to register your interest, please contact us at labeltech@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet Autumn agenda is themed around ‘PV2020+: Winning strategies for sustainable outcomes’ and will focus on the following:
- Spotlight on PV and Benefit-Risk Management in the COVID era
- Digital PV – Artificial Intelligence in Action
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect Autumn agenda is themed around ‘Optimizing labeling in 2021 and beyond’ and will focus on:
- Driving operational excellence through End-to-End oversight and enhanced labeling quality
- Achieving oversight of downstream activities
- Quality and QC – what does good look like and how do we measure?
- Devices and Combination Products: practical steps to deal with the new challenge
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech Autumn agenda is themed around ‘PV2020 – End-to-End Digital Safety Systems’ and will focus on the following:
- Regulatory Context and PV Technology
- Technology enabled Patient-to-Patient Safety
- Digital Transformation in PV
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet Autumn agenda is themed around ‘NextGen Labeling – People and Value in a Digital Environment’ and will focus on the following:
- Target Labeling: What metrics to use and how to operationalize
- Maximizing the digital environment: What is the landscape and how to fast track
- Workforce and Talent Development
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect Autumn agenda is themed around ‘Patient Engagement to Benefit-Risk Management – PV’s Potential’ and will focus on the following:
- Achieving ‘Audit Utopia’
- True effectiveness of aRMMs
- Data Science in PV
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
Navitas Data Sciences are pleased to be participating at the PHUSE EU Connect 2020 event.
Navitas Data Sciences are pleased to be participating at the PHUSE EU Connect 2020 event.
Sid Kumar, AVP Statistical Programming, Navitas Data Sciences will be taking to the virtual podium to present a session title Clinical Graphs using the Python packages. This session will be available via the event’s on demand platform.
To schedule a meeting with our team of experts and learn how we can help you to meet the future challenges of data requirements in your clinical trials, please click here.
For further information, please visit the event website at: https://www.phuse-events.org/attend/frontend/reg/thome.csp?pageID=256&eventID=2
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
The rimnet Autumn agenda is themed around ‘Leveraging initiatives and new technology for the RIM roadmap’ and will focus on:
- Regulatory Context
- Industry Context and the RIM Data Model
- RIM Data Governance: Business Drivers for RIM Imperatives
- Advanced Technology in Action
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
labeltech is a network for Regulatory and Labeling IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
labeltech is a network for Regulatory and Labeling IT professionals; focused on exploring end-to-end labeling technologies to improve processes and increase business value.
The labeltech Autumn agenda is themed around ‘Integrating Technology into the End-to-End Labeling Process’ and will focus on:
- Building an End-to-End Labeling Technology Roadmap
- Structured Content Authoring
For further information, or to register your interest, please contact us at labeltech@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet Autumn agenda is themed around ‘PV2020+: Winning strategies for sustainable outcomes’ and will focus on the following:
- Regulations – playing by the rules
- PV Strategy Models for Success
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech Autumn agenda is themed around ‘PV2020 – End-to-End Digital Safety Systems’ and will focus on the following:
- Regulatory Context and PV Technology
- Technology enabled Patient-to-Patient Safety
- Digital Transformation in PV
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect Autumn agenda is themed around ‘Optimizing labeling in 2021 and beyond’ and will focus on:
- Driving operational excellence through End-to-End oversight and enhanced labeling quality
- Achieving oversight of downstream activities
- Quality and QC – what does good look like and how do we measure?
- Devices and Combination Products: practical steps to deal with the new challenge
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet Autumn agenda is themed around ‘NextGen Labeling – People and Value in a Digital Environment’ and will focus on the following:
- Target Labeling: What metrics to use and how to operationalize
- Maximizing the digital environment: What is the landscape and how to fast track
- Workforce and Talent Development
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect Autumn agenda is themed around ‘Patient Engagement to Benefit-Risk Management – PV’s Potential’ and will focus on the following:
- Inspections – the new normal
- Engaging patients with impact
- Innovation and automation
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
KAI Research is growing, now part of the Navitas Life Sciences Enterprise, and will be rebranding as Navitas Clinical Research.
KAI Research is growing, now part of the Navitas Life Sciences Enterprise, and will be rebranding as Navitas Clinical Research.
We are pleased to be sponsoring the virtual 2020 BioHealth Capital Region Forum.
For further information, please visit the event website at: http://www.biohealthcapital.com/forum-2020/
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that this event will take place virtually. Registration is open, so please continue to register if you wish to participate.
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
We are delighted to be hosting our 9th forum this Autumn. The agenda for this event is themed around PV Regulatory and Technology Excellence – A continued journey and will focus on the following:
- Industry context
- Reflections on current Regulatory landscape
- Operational excellence through PV Automation and Artificial Intelligence
For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com
Navitas Data Sciences are sponsoring and exhibiting at the CDISC 2020 US Interchange. As the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences, we are a CDISC Registered Solutions Provider and Platinum Member delivering high quality data while ensuring regulatory compliance.
Navitas Data Sciences are sponsoring and exhibiting at the CDISC 2020 US Interchange. As the Functional Service Provider (FSP) of Data Services for Navitas Life Sciences, we are a CDISC Registered Solutions Provider and Platinum Member delivering high quality data while ensuring regulatory compliance.
Our expert, Steve Light, will be presenting a live demo of our CR Toolkit® Macro Library on Thursday 08 October between 12:30 and 13:00 EDT
Visit our virtual booth and learn how we can help you to meet the future challenges of Data Requirements in your clinical trials.
Visit our virtual booth and learn how we can help improve your clinical trial outcomes.
To schedule a meeting with our team of experts please click here.
For further information, please visit the event website at: https://www.cdisc.org/events/interchange/2020-cdisc-us-interchange
KAI Research is growing, now part of the Navitas Life Sciences Enterprise, and will be rebranding as Navitas Clinical Research.
KAI Research is growing, now part of the Navitas Life Sciences Enterprise, and will be rebranding as Navitas Clinical Research.
We are pleased to be both speaking and exhibiting at the upcoming Bio Innovation Conference.
Our President of Clinical Research, Kathy Dimeo, will be sharing insights gleaned from our recent patient centric COVID-19 clinical trials as well as looking at the strategic approaches we have taken to mitigate and manage non COVID-19 clinical trials throughout the pandemic.
Visit our virtual booth and learn how we can help improve your clinical trial outcomes.
To schedule a meeting with our team of experts please click here.
For further information, please visit the event website at: https://www.marylandlifesciences.com/conference/
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.
This roundtable meeting will explore Next Generation Medical Governance Models – with a spotlight on patient engagement and the digital era.
Please be advised that this is an invitation only event.
For further information please contact us at cmonet@navitaslifesciences.com
The DIA’s Regulatory Science Forum is a platform for sharing knowledge derived from regulatory science research and analyses conducted at the academic,
The DIA’s Regulatory Science Forum is a platform for sharing knowledge derived from regulatory science research and analyses conducted at the academic, industry, and regulatory levels, promoting open dialogue between all stakeholders.
On Wednesday 30 September, between 15:45 and 16:45 (CET) Navitas Life Sciences’ Labeling Though Lead, Tris Nockles, will be presenting on ‘Trends and Best Practices for Outsourcing and/or Offshoring for Labeling Operations’
For further information please visit the event website: https://www.diaglobal.org/en/conference-listing/meetings/2020/05/regulatory-science-forum#showcontent
Kathy Dimeo, the President of KAI Research, Inc., a Navitas Life Sciences enterprise, will be sharing our clinical trial expertise and COVID-19
Kathy Dimeo, the President of KAI Research, Inc., a Navitas Life Sciences enterprise, will be sharing our clinical trial expertise and COVID-19 experiences in a conversation with Marty Rosendale, CEO of the Maryland Tech Council (MTC). The virtual event “Coffee with CEOs” is conducted by MTC and is free for members.
To register for the event, click here.
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios.
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
We are delighted to be hosting our 9th forum this Spring. The agenda for this event is themed around PV Regulatory and Technology Excellence – A continued journey and will focus on the following:
- Industry context
- Reflections on current Regulatory landscape
- Operational excellence through PV Automation and Artificial Intelligence
For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com
Navitas Life Sciences are pleased to attend at the upcoming Bio Asia 2020 conference in Hyderabad, India.
Navitas Life Sciences are pleased to attend at the upcoming Bio Asia 2020 conference in Hyderabad, India.
BioAsia is a comprehensive framework dedicated to investors, researchers, start-ups, conglomerates in biotechnology, pharma, and to create business paradigms for the ever-evolving needs of the Lifesciences industry. The theme 'Today for Tomorrow 'explores the capabilities that Life sciences companies should invest in Today to thrive and create value Tomorrow.
The conference also presents an opportunity for corporates to interact with government agencies by providing valuable feedback and recommendations on regulatory compliances, investments, policymaking and reforms needed for the scope of Lifesciences.
If you would like to meet with our subject matter experts onsite, then please click here to schedule a meeting.
For further information about the event, please visit the event website here.
Navitas Life Sciences are pleased to be supporting Sidley’s upcoming Life Sciences College event ‘Inside the Minds of Regulators – Perspectives on EU Pharmaceutical and Medical Devices Law’
Navitas Life Sciences are pleased to be supporting Sidley’s upcoming Life Sciences College event ‘Inside the Minds of Regulators – Perspectives on EU Pharmaceutical and Medical Devices Law’
The event will bring together senior members of the European Commission and industry thought leaders. This interactive discussion will focus on a variety of topics, including the latest regulatory developments in the EU and the outlook for the life sciences industry as a whole. Hot topics to be addressed include:
- Update on recent key EU regulatory law developments
- IP incentives review and outlook for IP regulatory rights
- GDPR and EU data protection
- Regulatory aspects of EU competition law
- The changing landscape of medical devices and IVDs in Europe
- The World Health Organization’s fair pricing initiative
- Registries and real-world evidence
Navitas Life Sciences’ Latika Sharma, PV Networks Lead, will presenting at this event alongside Dr Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in a session chaired by Maarten Meulenbelt, Partner, Sidley, on the topic of the ‘Emerging Role of Real World Evidence (RWE) in the Pharmaceutical Industry’. If you would like to arrange to meet with Latika please click here.
For further information regarding the event please contact Cristina Menéndez Ruiz at Sidley: cmenendezruiz@sidley.com
Navitas Life Sciences are pleased to attending and exhibiting at the upcoming ISCR Conference 2020 in Mumbai, India.
Navitas Life Sciences are pleased to attending and exhibiting at the upcoming ISCR Conference 2020 in Mumbai, India.
The Indian Society for Clinical Research (ISCR) is an association of Indian clinical research professionals registered under the Societies Registration Act (1860). The Society brings together all those who are engaged in clinical research activities in India and provides a forum for exchange of information and learning. The conference will be attended by over 500 delegates from medical institutions, ethics committees, biopharmaceutical industry, government, patient organizations and clinical research organizations.
The 2020 edition aims to brings the clinical research community together to learn, connect, and explore opportunities to drive excellence in clinical research.
If you would like to meet with our subject matter experts onsite then please click here to schedule a meeting.
For further information about the event, please visit the event website here.
Navitas Life Sciences will be present at the 38th JP Morgan Healthcare conference in San Francisco from the 13th to 16th of January.
Navitas Life Sciences will be present at the 38th JP Morgan Healthcare conference in San Francisco from the 13th to 16th of January. Meet our experts Ram Yeleswarapu (President) and Subhashri Sriram (Chief Financial Officer) to learn how Navitas Life Sciences can enable you to drive better outcomes for your business.
For further information about the event, please visit the event website here
Navitas Life Sciences are pleased to attending and exhibiting at Booth #1 at the upcoming 14th Biosimilars Congregation, 2019 in Mumbai, India.
Navitas Life Sciences are pleased to attending and exhibiting at Booth #1 at the upcoming 14th Biosimilars Congregation, 2019 in Mumbai, India.
The event will bring together leading industry experts to discuss latest issues related to development, manufacturing to commercialization - The current landscape, legal, regulatory, funding, challenges, business models and go-to-market challenges related to Biosimilars in India.
If you would like to meet with our subject matter experts onsite then please click here to schedule a meeting.
For further information about the event, please visit the event website here.
Join our Safety experts as they look at how you can transform your End-to-End Safety Operations for greater visibility and control by leveraging leading edge technology.
Join our Safety experts as they look at how you can transform your End-to-End Safety Operations for greater visibility and control by leveraging leading edge technology.
This webinar will look at:
- How Navitas Life Sciences can provide absolute transparency and control of your safety operations
- How Oracle Argus enables greater flexibility, data security and regulatory compliance
- Why Navitas Life Sciences is best suited to take care of your clinical trial and post-marketing safety requirements
Presenters:
- Raj Srinivasan, Executive Business Partner – Safety & Regulatory Technology (EMEA & APAC) at Navitas Life Sciences
- Michael Braun-Boghos, Senior Director Safety Strategy at Oracle Health Sciences Business Unit
To register for this webinar, please click here.
Navitas Life Sciences are pleased to attending and exhibiting at booth #12 at the upcoming Clinical Operations in Oncology Trials Europe 2019. The event will bring together executives responsible for clinical operations in oncology.
Navitas Life Sciences are pleased to attending and exhibiting at booth #12 at the upcoming Clinical Operations in Oncology Trials Europe 2019. The event will bring together executives responsible for clinical operations in oncology.
If you would like to meet with our subject matter experts onsite then please contact us at marketing@navitaslifesciences.com to arrange a meeting.
For further information about the event, please visit the event website here.
Navitas Life Sciences are pleased to attending and exhibiting at Booth 80 at the upcoming Clinical Trials Europe conference. The event aims to drive innovation, collaboration, and new drug development;
Navitas Life Sciences are pleased to attending and exhibiting at Booth 80 at the upcoming Clinical Trials Europe conference. The event aims to drive innovation, collaboration, and new drug development; bringing together clinical trials stakeholders to swap insights, share knowledge, and gain new perspectives.
If you would like to meet with our subject matter experts onsite to discuss how we can transform your Clinical Trials through our Insights and Data-Driven Clinical Solutions that are customized to address your critical challenges then please contact us at marketing@navitaslifesciences.com to arrange a meeting.
For further information about the event, please visit the event website here.
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect November agenda is themed around Intelligent Labeling – processes by design and will focus on the following:
- Labeling implementation teams – role remit and interfaces, define decision making in governance
- Focus on inspections – experiences including with respect to outsourcing R&Rs
- Back translations – measuring the balance between effort and value
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect November agenda will address:
- Latest regulatory context - member responses to regulations and strategies for inspections
- The PV workforce – resource, capabilities, and vendors – how do we ensure we have the right people in the right roles?
- QMS, training and SOPs – best practices and future focus
- Automation of analytics in PV…continued – Experience share of live projects
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet November agenda is themed around Intelligent Labeling – realizing our full potential and will focus on the following:
- Early involvement, framework, TPP, TPLs interface between labeling and regulatory strategy leader
- Talent and capability – map key roles (early strategists, digital data science, labeling intelligence, vendor management) and feedback from working group
- Patients in labeling – patient centricity, RWE alternative data sources. Apps are devices in combination with medicinal products
- Digital and automation – mapping the end-to-end process looking for opportunities for automation
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech November agenda will address:
- The PV Safety Database: implementation and NextGen SDB
- PV Technology beyond the Safety Database: right sourcing for emerging technologies and technology deep dive
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
The rimnet November agenda is themed around NextGen RIM – focus on structured data and will address:
- Latest regulatory and industry context
- Structured data elements through the entire value chain – connecting structured data elements to the patient
- Revisit and update RIM Maturity Model – focus on process
- RMM – candidate for industry standard approach
- Grandmaster File V2
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet November agenda is themed around NextGen PV – gearing up for success and will focus on the following:
- Latest regulatory and industry context
- Regulatory intelligence and HA influencing
- PV automation and analytics... a continued conversation
- How to gear up – talent, capability, and partnering
- Community way forward
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling...
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect November agenda is themed around Intelligent Labeling – processes by design and will focus on the following:
- Labeling implementation teams – role remit and interfaces, define decision making in governance
- Focus on inspections – experiences including with respect to outsourcing R&Rs
- Back translations – measuring the balance between effort and value
For further information, or to register your interest, please contact us at labelconnect@navitaslifesciences.com
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling...
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet November agenda is themed around Intelligent Labeling – realizing our full potential and will focus on the following:
- Early involvement, framework, TPP, TPLs interface between labeling and regulatory strategy leader
- Talent and capability – map key roles (early strategists, digital data science, labeling intelligence, vendor management) and feedback from working group
- Patients in labeling – patient centricity, RWE alternative data sources. Apps are devices in combination with medicinal products
- Digital and automation – mapping the end-to-end process looking for opportunities for automation
For further information, or to register your interest, please contact us at labelnet@navitaslifesciences.com
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments...
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The pvtech November agenda will address:
- The PV Safety Database: implementation and NextGen SDB
- PV Technology beyond the Safety Database: right sourcing for emerging technologies and technology deep dive
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one...
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The pvconnect November agenda will address:
- Latest regulatory context - member responses to regulations and strategies for inspections
- The PV workforce – resource, capabilities, and vendors – how do we ensure we have the right people in the right roles?
- QMS, training and SOPs – best practices and future focus
- Automation of analytics in PV... continued – Experience share of live projects
For further information, or to register your interest, please contact us at pvconnect@navitaslifesciences.com
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
The rimnet November agenda is themed around NextGen RIM – focus on structured data and will address:
- Latest regulatory and industry context
- Structured data elements through the entire value chain – connecting structured data elements to the patient
- Revisit and update RIM Maturity Model – focus on process
- RMM – candidate for industry standard approach
- Grandmaster File V2
For further information, or to register your interest, please contact us at rimnet@navitaslifesciences.com
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies...
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet November agenda is themed around NextGen PV – gearing up for success and will focus on the following:
- Latest regulatory and industry context
- Regulatory intelligence and HA influencing
- PV automation and analytics... a continued conversation
- How to gear up – talent, capability, and partnering
- Community way forward
For further information, or to register your interest, please contact us at pvnet@navitaslifesciences.com
Navitas Life Sciences are pleased to be attending the upcoming Outsourcing in Clinical Trials Nordics 2019 event...
Navitas Life Sciences are pleased to be attending the upcoming Outsourcing in Clinical Trials Nordics 2019 event. This event will explore how to accelerate trial timelines and cut costs by reducing inefficiencies in global supply chains.
If you would like to meet with our subject matter experts onsite to learn how you can gain a competitive edge throughout your clinical development process then please contact us at marketing@navitaslifesciences.com to arrange a meeting.
For further information about the event, please visit the event website here.
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios...
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
We are delighted to be hosting our 8th forum this autumn. The agenda is themed around Empowering PV operations with proactive regulatory compliance and NextGen PV automation and will focus on the following:
- Global & Domestic Regulatory Updates
- Taking Regulatory compliance to the next level
- Achieving operational excellence through PV Automation and Artificial Intelligence (AI)
For further information, or to register your interest, please contact us at pvindia@navitaslifesciences.com
Navitas Life Sciences are pleased to be attending the upcoming Outsourcing in Clinical Trials DACH 2019 event...
Navitas Life Sciences are pleased to be attending the upcoming Outsourcing in Clinical Trials DACH 2019 event. The event will explore the operational challenges facing clinical development in Germany, Austria, and Switzerland.
If you would like to meet with our subject matter expert onsite to learn how you can gain a competitive edge throughout your clinical development process then please contact us at marketing@navitaslifesciences.com to arrange a meeting.
For further information about the event, please visit the event website here.
Navitas Life Sciences are pleased to be attending the upcoming UK Biotech Summit. The event will look at the evolving design of cancer drug trials, the ways in which oncology studies will...
Navitas Life Sciences are pleased to be attending the upcoming UK Biotech Summit. The event will look at the evolving design of cancer drug trials, the ways in which oncology studies will be adapted in the coming years, and the influence that will have on developers in general, regardless of disease.
If you would like to meet with our team onsite to discuss how you can transform your clinical trials through our insights and data-driven clinical solutions that are customized to your critical challenges, then please contact us at marketing@navitaslifesciences.com to arrange a meeting.
For further information about the event, please visit the event website here
Navitas Life Sciences are pleased to be exhibiting at booth #605 at the upcoming SCDM 2019 conference; celebrating the 25th anniversary of SCDM...
Navitas Life Sciences are pleased to be exhibiting at booth #605 at the upcoming SCDM 2019 conference; celebrating the 25th anniversary of SCDM. If you would like to meet our subject matter experts to discover how you can transform your Clinical Trials through our Insights and Data Driven Clinical Solutions that are customized to address your critical challenges then please click here to schedule a meeting.
For further information about the conference, please visit the event website here
Meet with our Regulatory experts at RAPS booth 345 and leverage our experience to improve your Regulatory strategy and processes.
Meet with our Regulatory experts at RAPS booth 345 and leverage our experience to improve your Regulatory strategy and processes.
We are proud to have more than 70,000 regulatory submissions under our belt. At Navitas Life Sciences we have the insights to support the regulatory end-to-end lifecycle management across the entire value chain of the drug and device regulatory environment.
If you would like to arrange a meeting with a member of our team then please click here.
For further information about the meeting, please visit the event website here
Navitas Life Sciences are pleased to be attending the upcoming Oracle Health Sciences Safety Consortium Meeting. This is the first European face-to-face meeting...
Navitas Life Sciences are pleased to be attending the upcoming Oracle Health Sciences Safety Consortium Meeting. This is the first European face-to-face meeting replacing the previously held Oracle Safety Focus Group events. This meeting will provide Oracle Argus and Oracle Health Sciences Empirica product updates and demonstrations as well as looking at pharmacovigilance hot topics. Together attendees will also look to explore how Artificial Intelligence will revolutionize case processing in the coming year, the latest drug safety regulations, and look at the benefits of moving to the cloud.
If you would like to meet with our subject matter experts onsite then please contact us at marketing@navitaslifesciences.com to arrange a meeting.
For further information about the meeting, please visit the event website here.
Navitas Life Sciences’ Global Head for Generics, Dr Ayaaz Khan will be one of the speakers at the ‘The Economic Times L.I.F.E. Summit’...
Navitas Life Sciences’ Global Head for Generics, Dr Ayaaz Khan will be one of the speakers at the ‘The Economic Times L.I.F.E. Summit’ (Life Sciences Industry Forum for Excellence), taking place on 23rd August 2019 at Taj Krishna, Hyderabad contributing to the theme ‘Product Innovation & Development – Biosimilars - The race is on!’
For further information about ‘The Economic Times L.I.F.E. Summit’ (Life Sciences Industry Forum for Excellence), please visit the event website here
Navitas Life Sciences are pleased to be attending and presenting at Sidley’s pvlegal Biannual Meeting...
Navitas Life Sciences are pleased to be attending and presenting at Sidley’s pvlegal Biannual Meeting. The event will include hot topics in Pharmacovigilance (US and EU), benchmarking trends, and practical case studies on industry issues.
Navitas Life Sciences’ Zuby Okemefuna, Senior Consultant, will co-present a case study, Safety Information Communication Tool, with Todd Rudo and Kevin Tynan of CSL Behring. If you would like to arrange to meet with Zuby please contact us at marketing@navitaslifesciences.com
About pvlegal
pvlegal is a membership based forum for in-house counsel and compliance personnel at pharmaceutical companies working on pharmacovigilance issues in the Life Sciences sector. This is supported by regular benchmarking of member performance and best practice sharing in the areas of drug safety. Sidley Austin LLP serves as counsel to pvlegal. Additional support and sponsorship is provided by Navitas Life Sciences. For further information please contact pvlegal@sidley.com
Navitas Life Sciences’ are delighted to be exhibiting at booth #954 the DIA 2019 Global Annual Meeting...
Navitas Life Sciences’ are delighted to be exhibiting at booth #954 the DIA 2019 Global Annual Meeting.
If you would like to meet with our onsite team to learn how you can gain a competitive edge throughout your clinical development process then please click here
For further information about the conference, please visit the event website at: https://www.diaglobal.org/en/flagship/dia-2019
Live Webinar: Leveraging Technology for Improved Outcomes across End-to-End Labeling
Time: 10:00 – 11:00 EST
End-to-End Labeling is one of the most complex cross-functional processes within the pharmaceutical industry. In order to meet regulatory expectations and ensure future success, it is necessary to develop a robust, scalable, and harmonized solution for the global labeling capability. Join our subject matter experts as they examine how leveraging technology can improve outcomes across your End-to-End Labeling processes.
This webinar will look at:
- Harnessing labeling technologies as a game changer for end-to-end process optimization and tangible outcomes
- Exploring conceptual models – moving from current state architecture towards a future state for labeling technology nirvana
- Extracting business value from your technology investments: moving from retrospective tracking to predictive analytics
Presenters:
Denis Fung, Head of Consulting Europe, Navitas Life Sciences
Zuby Okemefuna, Senior Consultant, Navitas Life Sciences
To register for this webinar, please click here.
8th Annual Regulatory Operations and Submissions
Venue: Renaissance Philadelphia Airport Hotel, Philadelphia, PA, USA
Navitas Life Sciences’ Chief Growth Officer, Dr. Krishnan Rajagopalan, will be presenting at the 8th Annual Regulatory Operations and Submissions conference:
Tuesday 11 June, 2019 11:00 – 11:45: Partnership Models for Global Submissions and Publishing
The session will explore:
- Industry challenges and priorities
- Benchmark metrics and insights
- Key objectives in Regulatory Affairs, Submissions/Publishing
- Partnership Model – Scope | Unit Pricing | Sample KRAs | Governance | Learnings
If you would like to meet with Krishnan to find out more about our services and discuss how you can leverage our knowledge process outsourcing and technology capabilities to support your organization’s regulatory environment then please contact marketing@navitaslifesciences.com
For further information about the conference, please visit the event website at: https://www.q1productions.com/regops/
13th Biosimilars Congregation 2019
Venue: Pestana Chelsea Bridge Hotel, London, UK
Navitas Life Sciences’ Client Partner, Vencislav Cheshmedzhiev, will be attending the 13th Biosimilars Congregation.
If you would like to meet with Vencislav to find out more about our Biosimilars capabilities and discuss how you can leverage OneClinical, our optimized eClinical and analytics platform or comprehensive trial oversight, faster decisions, and better outcomes then please contact marketing@navitaslifesciences.com
For further information about the conference, please visit the event website at: https://www.virtueinsight.com/pharma/13th-Biosimilars-Congregation-2019/
labeltech Forum - Spring
Time: Registration from 08:00 | Meeting 08:30 – 16:00
Venue: Apella, New York, USA
labeltech is a network for Regulatory or Labeling IT professionals focused on exploring E2E labeling technologies to improve processes and increase business value.
The labeltech June agenda is themed around 'Streamlining the future with technology' and will focus on the following:
- Overarching systems
- Digital health
- SCA, Automation, Artificial Intelligence, and Apps
pvconnect Forum - Spring
Time: Registration from 08:00 | Meeting 08:30 – 16:00
Venue: Apella, New York, USA
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The meeting agenda will address
- Latest regulatory context: member responses to regulations and strategies for inspections
- Automation experience share - lessons learned and next steps
- Impact on PV organisation and capabilities – spotlight on interaction with outsourcing
- Modern metrics
pvtech Forum - Spring
Time: Registration from 08:00 | Meeting 08:30 – 16:00
Venue: Apella, New York, USA
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The meeting agenda will address:
- EVDAS - updates and learnings
- Safety database upgrades - top tips for success
- PV technology landscape - beyond the Safety Database
- Mapping tools and gaps for safety science
labelnet Forum - Spring
Time: Registration from 08:00 | Meeting 08:30 – 16:00
Venue: Apella, New York, USA
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet June agenda is themed around 'Intelligent Labeling' and will focus on the following:
- Early involvement, framework, TPP, and TPLs
- Patient centricity and RWE
- Competencies and resources - talent management and offshoring
labelconnect Forum - Spring
Time: Registration from 08:00 | Meeting 08:30 – 16:00
Venue: Apella, New York, USA
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect June agenda is themed around 'Optimizing the E2E Labeling Process' and will focus on the following:
- Interfaces with PV and SC
- Vendor and partner management
- QC, labeling standard, and how to track
pvnet Summit - Spring
Time: Registration from 08:00 | Meeting 08:30 – 16:00
Venue: Apella, New York, USA
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet June agenda is themed around 'PV Evolution - spotlight on analytics, alliances, and agility'.
- Latest regulatory and industry context with benchmark highlights
- Digital journey - spotlight on PV analytics and data
- Alliances in action - vendors, affiliates, academia, and regulators
- PV budgets and productivity measures in a digital era
rimnet Forum - Spring
Time: Registration from 08:00 | Meeting 08:30 – 16:00
Venue: Apella, New York, USA
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
The rimnet June agenda is themed around 'New solutions to existing challenges' and will focus on the following:
- Technology: vendor showcase; Artificial Intelligence, Automations, and RIM; SCA
- Process: Data modelling/data standards - establish core data model; Process engineering to bring on RIM; Supply Chain Management and Regulatory Operations Management
- Strategy: Cross functional interactions; System, Clinical and RA interactions; Bridge CMC, Clinical, and Regulatory
- Regulations: Regulatory intelligence, IDMP
8th Annual Global Pharma Regulatory Summit
Venue: The Lalit Mumbai, India
Navitas Life Sciences will be present at the 8th annual Global Pharma Regulatory Summit from 29 -31 May 2019 at The Lalit Mumbai, India. Raj Srinivasan, VP – Business Partner, Safety & Regulatory will be speaking on the topic "Journey towards regulatory excellence by leveraging technology" on Day 3 of the summit. pharmaREADY will also be demonstrated at the summit.
The 8th Edition of Global Pharma Regulatory Summit is a platform where key leaders and experts of regulatory affairs, compliances, quality assurance and policy makers discuss the current trends and challenges in global regulatory landscape. The forum will discuss the latest challenges in the regulatory environment and examine the impact of new initiatives for emerging markets, review the global perspective of regulatory system and understand how companies world over will revamp pharma regulatory strategies.
For further information, or to register your interest, please contact us at: https://navitaslifesciences.pages.salesfusion.com/8th-Annual-Global-Pharma-Regulatory-Summit-2019
labeltech Forum - Spring
Time: 08:30 – 14:30
Venue: Sidley Austin LLP Offices, London, UK
labeltech is a network for Regulatory or Labeling IT professionals focused on exploring E2E labeling technologies to improve processes and increase business value.
The labeltech May agenda is themed around 'Streamlining the future with technology' and will focus on the following:
- Overarching systems
- Digital health
- SCA, Automation, Artificial Intelligence, and Apps
labelnet Forum - Spring
Time: Registration from 09:00 | Meeting 09:30 – 16:30
Venue: Sidley Austin LLP Offices, London, UK
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
The labelnet May agenda is themed around 'Intelligent Labeling' and will focus on the following:
- Early involvement, framework, TPP, and TPLs
- Patient centricity and RWE
- Competencies and resources - talent management and offshoring
labelconnect Forum - Spring
Time: Registration from 09:00 | Meeting 09:30 – 16:30
Venue: Sidley Austin LLP Offices, London, UK
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
The labelconnect May agenda is themed around 'Optimizing the E2E Labeling Process' and will focus on the following:
- Interfaces with PV and SC
- Vendor and partner management
- QC, labeling standard, and how to track
pvconnect Forum - Spring
Time: Registration from 09:00 | Meeting 09:30 – 16:30
Venue: Sidley Austin LLP Offices, London, UK
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
The meeting agenda will address
- Latest regulatory context: member responses to regulations and strategies for inspections
- Automation experience share - lessons learned and next steps
- Impact on PV organisation and capabilities - spotlight on interaction with outsourcing
- Modern metrics
rimnet Forum - Spring
Time: Registration from 09:00 | Meeting 09:30 – 16:30
Venue: Sidley Austin LLP Offices, London, UK
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
The rimnet May agenda is themed around 'New solutions to existing challenges' and will focus on the following:
- Technology: vendor showcase; Artificial Intelligence, Automations, and RIM; SCA
- Process: Data modelling/data standards - establish core data model; Process engineering to bring on RIM; Supply Chain Management and Regulatory Operations Management
- Strategy: Cross functional interactions; System, Clinical and RA interactions; Bridge CMC, Clinical, and Regulatory
- Regulations: Regulatory intelligence, IDMP
pvnet Summit - Spring
Time: Registration from 09:00 | Meeting 09:30 – 16:30
Venue: Sidley Austin LLP Offices, London, UK
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
The pvnet May agenda is themed around 'PV Evolution - spotlight on analytics, alliances, and agility'
- Latest regulatory and industry context with benchmark highlights
- Digital journey – spotlight on PV analytics and data
- Alliances in action – vendors, affiliates, academia, and regulators
- PV budgets and productivity measures in a digital era
pvtech Forum - Spring
Time: Registration from 09:00 | Meeting 09:30 – 16:30
Venue: Sidley Austin LLP Offices, London, UK
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
The meeting agenda will address:
- EVDAS - updates and learnings
- Safety database upgrades - top tips for success
- PV technology landscape - beyond the Safety Database
- Mapping tools and gaps for safety science
Sparta Connection 2019
Venue: Hilton La Jolla Torrey Pines, CA, USA
Navitas Life Sciences’ Client Partner, Dr. Peder Seglund, will be in attendance at the Sparta Connection 2019 event and will speak to Quality Professionals about TrackWise support, web services, and Quality Connect Integrations.
The 2019 conference is themed around ‘Making Digital Quality and Reality’. We are proud to have completed one of the first TrackWise digital implementations in the industry. If you would like to meet with Dr. Seglund to learn how you can optimize your TrackWise investment, then please contact marketing@navitaslifesciences.com
For further information about the conference, please visit the event website here
ctlegal Biannual Meeting
Venue: Incyte offices, Wilmington, Delaware, USA
Navitas Life Sciences are pleased to be attending Sidley’s ctlegal Biannual Meeting. This interactive meeting will include hot topics in clinical trials (EU and USA), benchmarking trends, and practical case studies on industry issues. Agenda topics include:
- Investigator Sponsored Research
- Clinical Trial Agreements
- Post Approval Access
- Subject Injuries and Reporting
About ctlegal
ctlegal is a membership-based forum for in-house counsel and compliance personnel at pharmaceutical companies working on clinical trial issues in the Life Sciences sector. This is supported by regular benchmarking of member performance and best practice sharing in the area of clinical trials. Sidley Austin LLP serves as counsel to ctlegal and support and sponsorship is provided by Navitas Life Sciences. For further information please contact ctlegal@sidley.com.
9th Annual Outsourcing in Clinical Trials Europe 2019
Venue: Milan, Italy
Navitas Life Sciences’ Client Partner, Piet Smet, will be in attendance at the 9th Annual Outsourcing in Clinical Trials Europe 2019 event. The conference will discuss ever-pressing partnership and outsourcing challenges as well as having a dedicated track to address clinical trial technology and data.
If you would like to meet with Piet Smet to find out more about our services and discuss how you can leverage OneClinical, our optimized eClinical and analytics platform offering comprehensive trial oversight and enabling fast decisions, then please contact marketing@navitaslifesciences.com
For further information about the conference, please visit the event website at: http://www.arena-international.com/octeurope/
Oracle Health Sciences Connect 2019 Conference
Time & Venue: 9:15am EST | DoubleTree by Hilton Philadelphia Center City, Philadelphia, Pennsylvania
John D'Antonio, Global Head of Consulting, Navitas Life Sciences, will provide a case study on how companies are moving to the Cloud to reduce costs, expedite implementations and/or upgrades, and ensures data security and privacy at the Oracle Health Sciences Connect 2019 Conference in Philadelphia, Pennsylvania on Wednesday, April 10, 2019, at 9:15am EST.
To meet with our experts at the conference, please visit click here.
eRegulatory Summit
Venue: Crowne Plaza Barcelona - Fira Center, Barcelona, Spain
Navitas Life Sciences are both speaking and exhibiting at the eRegulatory Summit. The event will bring together the innovators of the changing face of Information Management and eSubmissions to look at telematics, RIM, eCTD, IDMP, and filing variations – providing actionable insights to improve regulatory strategy.
On Monday 08 April, 2019 between 10:20 – 10:55, Navitas Life Sciences’ Global Head of Regulatory and Safety, Marty Boom, will be presenting a session titled: ‘Strategic progression to RIM excellence – transforming information into intelligence and insights’. This session will:
- RIM Maturity Model: Building a single, consistent, and reliable source of truth
- Integrating processes to drive value across the RIM landscape
- Turning Regulatory information into intelligence and insights to enhance integrated processes
If you would like to meet with a member of our team please contact marketing@navitaslifesciences.com
pvlegal Biannual Meeting
Venue: Sanofi Offices, Paris, France
Navitas Life Sciences are pleased to be attending Sidley’s pvlegal Biannual Meeting. The event will include hot topics in pharmacovigilance (EU and USA), benchmarking trends, and practical case studies on industry issues.
Navitas Life Sciences’ Louise Tan, Senior Consultant – PV Thought Lead, will be in attendance at this event. If you would like to arrange to meet with Louise please contact us at marketing@navitaslifesciences.com
About pvlegal
pvlegal is a specialized forum for in-house counsel and compliance personnel working on drug and device safety issues in the Life Sciences sector. Sidley Austin LLP serves as counsel to pvlegal. Additional support and sponsorship is provided by Navitas Life Sciences. For further information please contact pvlegal@sidley.com
pvindia Forum - Spring
Venue: Mumbai, India
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
We are delighted to be hosting our 7th forum, which will include:
- Context and Regulatory update
- PV today – moving towards operational excellence
- Automation and how it fits into the PV evolution
Live Webinar: Automation, Analytics and Artificial Intelligence (AI) – A Roadmap to NextGen Pharmacovigilance (PV) Technology
Time: 10:00 – 11:00 EST
Join our subject matter expert as she examines the role of Automation, Analytics and AI within PV organizations. The current state of the industry is at an inflection point with stakeholders investing in new and collaborative ways of working.
This webinar, the first in a series on NextGen PV Technology Transformation, will discuss the building blocks needed to develop an early adoption strategy for successful Transformation.
Using illustrative case studies and industry benchmarks we will explore:
- A metrics driven approach to automation – the what, when, and how
- A value driven approach to developing an analytics program
- An efficiency driven approach to adoption of AI technologies
Presenter:
Rekha Illuri, Senior Managing Consultant, Navitas Life Sciences
To register for this webinar, please click here
Life Sciences College: Inside the Minds of Regulators – Perspectives on EU Pharmaceutical and Medical Devices Law
Venue: The Hotel Brussels, Brussels, Belgium
Navitas Life Sciences are pleased to be supporting Sidley’s upcoming Life Sciences College event ‘Inside the Minds of Regulators – Perspectives on EU Pharmaceutical and Medical Devices Law’
The event will look at how the latest legal and regulatory developments in EU law will affect companies operating in the Life Sciences space. It will bring together senior and former members of the European Commission, the European Medicines Agency, the Dutch Medicines Evaluation Board, the Swiss Agency for Therapeutic Products, the US Food and Drug Administration, as well as representatives from the regulatory and business community to address key issues.
Panel discussions will cover clinical trials, pharmacovigilance, orphan drugs, new pathways to marketing authorizations, falsified medicines, pharmaceutical incentives, transparency on pricing, pharmacy compounding, advanced therapy medicinal products (ATMPs), fees, off-label use, biosimilars, medical devices and Brexit among other topics.
Navitas Life Sciences’ Piet Smet, Client Partner and Sara Giadrossi, Networks Operations Manager, will be in attendance at this event. If you would like to arrange to meet with Piet or Sara, please contact us at marketing@navitaslifesciences.com
For more information, visit here
Women’s Life Sciences Network: EU/US Perspectives on Innovation and Market Access
Venue: The Hotel Brussels, Brussels, Belgium
Time: 18:00 – 20:30
Navitas Life Sciences are pleased to be attending Sidley’s Women’s Life Sciences Network event ‘EU/US Perspectives on Innovation and Market Access’
The event will feature a discussion with Kristine Peers, General Counsel, European Federation of Pharmaceutical Industries (EFPIA) and Rebecca Wood, Partner, Sidley and Former Chief Counsel, Food and Drug Administration (FDA).
Kristine will focus on the challenging environment in Europe for the innovative pharmaceutical business, reflecting on the ongoing debate around patient access, IP incentives and innovation. Becky will discuss inflection points at the new FDA, as the agency modernizes its approach to biopharmaceutical innovation and competition.
Navitas Life Sciences’ Sara Giadrossi, Networks Operations Manager, will be in attendance at this event. If you would like to arrange to meet with Sara please contact us at marketing@navitaslifesciences.com
For further information about the event please contact Cristina Menendez Ruiz at cmenendezruiz@sidley.com
cmonet Meeting
Venue: GSK Offices, Philadelphia, USA
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics within the remit of the CMO.
Please be advised that this is an invitation only event.
For further information please contact us at cmonet@navitaslifesciences.com
KOWAL Foundation IT Suppliers’ Fair for FMD End Users
Venue: Airport Hotel Okęcie, Warszawa, Poland
Time: 09:30 – 17:00
This event, hosted by the KOWAL Foundation, will look at IT software solutions for verifying the authenticity of medicines in accordance with the Delegated Regulation 2016/161.
Navitas Life Sciences’ Vice President and Business Partner for Regulatory and Safety Technology, Varadarajan Srinivasan, will be in attendance showcasing our EU FMD Module for traceREADY
For further information or to register your attendance, please visit the KOWAL Foundation website here
To arrange to meet with a member of our team please contact marketing@navitaslifesciences.com
Partnerships in Clinical Trials Europe
Venue: CCIB, Barcelona, Spain
Navitas Life Sciences will conduct a Thought Leadership podium presentation at Partnerships in Clinical Trials Europe. Our Chief Growth Officer, Dr. Krishnan Rajagopalan together with Dr. Niranjan Rao, Vice President Clinical Development at Asana BioSciences will be presenting the session on Wednesday 28 November, 2018 at 15:00.
Leveraging AI based platform and analytics for RBM, CM/RM, trial operations, and improved outcomes
With the industry pursuing several new models transforming Clinical Trial operations, Dr. Rajagopalan and Dr. Rao will look to address some of the key topics below as part of the discussion:
- An Overview of the Challenges in the Clinical Trials Landscape and the Drivers towards Innovations
- Leveraging Operating Models - Risk Based Monitoring (RBM), Quality by Design (QdB), and CM/RM
- Technology developments and considerations – AI, automation, and digital approaches
- Case study: ‘Implementing innovative technology’ – looking at how Navitas Life Sciences’ OneClinical (an integrated clinical enterprise platform) is leveraged to optimize data integration, analytics and data visualization and some pivotal decisions on the study
For further information, please visit the event website here
Live Webinar: Clinical and Regulatory Data Convergence: Increasing Enterprise Value
Time: 11:00 – 12:00 EST 1600-1700z (GMT) – 21:30 – 22:30 IST
Join our subject matter experts as they explore the topic of Clinical and Regulatory data convergence and how you can improve information flow to increase enterprise value.
This webinar will explore:
- Industry challenges related to content management and data re-use across the drug development life-cycle
- Evolution of life sciences data and technologies that support clinical and regulatory data convergence
- Clinical and regulatory touch points and opportunities to improve data flow and information management
Presenters:
Tom Beatty, Senior Managing Consultant - Regulatory, Navitas Life Sciences
Hershell Thompson, Senior Managing Consultant – Clinical, Navitas Life Sciences
To register for this webinar, please click here.
rimnet Forum - Autumn
(across our PV and Regulatory portfolio)
Date: 14 November, 2018 – rimnet Forum
Venue: New York, USA
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- The latest RIM context and Regulatory updates
- Implementing risk based global processes
- Systems integration
pvnet Summit – Autumn
(across our PV and Regulatory portfolio)
Date: 14 November, 2018 – pvnet Forum
Venue: New York, USA
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- The latest Regulatory insights
- PV automation
- PV workforce of the future
- Vendors, value, and how to measure success
labelnet Forum - Autumn
(across our PV and Regulatory portfolio)
Date: 14 November, 2018 – labelnet Forum
Venue: New York, USA
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- Regulatory insights and Reference Labeling
- Development Labeling – what does good look like?
- How to build a business case for strategic labeling
labelconnect Forum - Autumn
(across our PV and Regulatory portfolio)
Date: 14 November, 2018 – labelconnect Forum
Venue: New York, USA
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- Regulatory insights and Reference Labeling
- Labeling for different sectors: Devices, Combination Products, Biosimilars, and Consumer Products
- Next generation competencies and resourcing
pvtech Forum - Autumn
Venue: New York, USA
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
pvconnect Forum - Autumn
(across our PV and Regulatory portfolio)
Date: pvconnect Forum
Venue: New York, USA
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- Regulatory update
- Vendor management – new perspectives
- Benefit Risk management – future focus
- Leveraging data and technology
Live Webinar: EU FMD Compliance – Are You Ready?
Time: 10:00 – 11:00 EST
The Falsified Medicines Directive (FMD) introduces harmonized European measures to prevent falsified medicines from entering the legal supply chain. Companies that manufacture, sell or dispense drugs in the European Union have until February 9, 2019 to comply.
Are you READY?
Join us as we discus how you can speed up your efforts to meet the EU FMD deadline with innovative industry leading technology.
Presenters:
Govind Srinivasan, Vice President, Technology, Navitas Life Sciences
Bill Fletcher, Managing Partner, Pharma Logic Solutions, LLC
To register for this webinar, please click here.
labelnet Forum - Autumn
(across our PV and Regulatory portfolio)
Date: 08 November, 2018 – labelnet Forum
Venue: London, UK
labelnet is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on strategic aspects of the full lifecycle of labeling.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- Regulatory insights and Reference Labeling
- Development Labeling – what does good look like?
- How to build a business case for strategic labeling
labelconnect Forum - Autumn
(across our PV and Regulatory portfolio)
Date: 08 November, 2018 – labelconnect Forum
Venue: London, UK
labelconnect is a network for labeling leaders of large and mid-sized life sciences companies, with a specific focus on operational aspects of the full lifecycle of labeling.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- Regulatory insights and Reference Labeling
- Labeling for different sectors: Devices, Combination Products, Biosimilars, and Consumer Products
- Next generation competencies and resourcing
rimnet Forum - Autumn
(across our PV and Regulatory portfolio)
Date: 08 November, 2018 – rimnet Forum
Venue: London, UK
rimnet is a network for Global Heads of Regulatory Affairs and RIM IT professionals to create transformational enterprise solutions for Regulatory Information Management.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- The latest RIM context and Regulatory updates
- Implementing risk based global processes
- Systems integration
pvtech Forum - Autumn
Venue: London, UK
pvtech is a network for Heads of Information Technology for PV departments, focused on increasing business value from technology investments.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
For further information, or to register your interest, please contact us at pvtech@navitaslifesciences.com
pvconnect Forum - Autumn
Date: 07 November, 2018 – a cross network event for all members
(across our PV and Regulatory portfolio)
Venue: London, UK
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life science companies with a range of product portfolios including one or more of Pharma, Biologicals, Consumer, and Medical Devices.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- Regulatory update
- Vendor management – new perspectives
- Benefit Risk management – future focus
- Leveraging data and technology
pvnet Summit – Autumn
Date: 07 November, 2018 – a cross network event for all members
(across our PV and Regulatory portfolio)
Venue: London, UK
Established in 2001, pvnet is a network for Heads of Safety of top 30 life sciences companies, invests in thought leadership to help shape future practices.
We are delighted to offer a two day meeting this November, to include a unique one day session across our portfolio of PV and Regulatory networks. Our aim is to:
- Provide a rich and practical perspective on the latest technology innovations – how automation and analytics are changing our world
- Host a deep dive discussion on the cross functional interfaces across the overarching (patient to patient) E2E PV and labeling process
- Ensure focused discussion on hot topics emerged at recent forums and the latest industry benchmark data
- The latest Regulatory insights
- PV automation
- PV workforce of the future
- Vendors, value, and how to measure success
pvindia Forum - Autumn
Venue: Mumbai, India
pvindia is a network for PV leads of life sciences companies in the APAC region with Pharma, Consumer, Generics, or mixed portfolios. Launched in March, 2016 pvindia provides a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
We are delighted to be hosting our 6th forum, which will include:
- A roundtable discussion on recent achievements and forthcoming challenges
- A look at the latest Indian and International Regulatory context
- Vision of the PV space 3-5 years from now
- Optimising the handling of PV agreements
- EudraVigilance data
CPhI Worldwide
Venue: IFEMA – Feria de Madrid, Spain
Navitas Life Sciences will be at the CPhI Worldwide conference October 9-11, 2018. CPhI is an established pharmaceutical event with experience of bringing together over 25 thousand pharmaceutical executives from throughout the world.
We welcome you to Stand No. 3A102, Hall 3, to learn about your key objectives and to demonstrate how you can leverage Navitas Life Sciences’ industry expertise to overcome your challenges and beat your competitors to market. To schedule a meeting, click here
BioForward – The ‘Roadmap for Growth’ Life Sciences Event
Venue: Birmingham University, Birmingham, UK
BioForward is an international conference focused on creating and developing a practical roadmap for early stage, emerging, and developing life sciences companies to achieve sustainable business success and growth. The event is aimed at professionals who are keen to gain the knowledge, skills, connectivity, and support necessary to maximise their chances of success and efficiently navigate through the various development phases to market and beyond.
Navitas Life Sciences are delighted to be exhibiting at this event. Meet with our subject matter experts, Dr. Krishnan Rajagopalan and Neil Cummins at Stand No. 4 to discover how you can transform your Clinical Trials through our insight driven Clinical, Regulatory, and Safety solutions that are customised to address your critical challenges and help you to gain a competitive advantage.
For further information, please visit the event website here.
Regulatory Affairs Professionals Society Regulatory Convergence
Venue: Vancouver Convention Center West Vancouver, Canada
Meet with Navitas Life Sciences at the RAPS Regulatory Convergence conference at booth 605 to learn how you can seamlessly integrate your regulatory processes to derive greater benefits from your Regulatory Information Management investments.
For more information about the conference, click here
SCDM 2018 Annual Conference
Venue: Hyatt Regency Bellvue Grand Ballroom, Seattle, USA
The SCDM 2018 annual conference will explore cutting edge solutions and best practices in the Clinical Data Management industry.
Meet with us at booth 112 to discover how you can leverage OneClinical, our eClinical and analytics platform, to better manage trials, reduce risks, and make informed decisions.
For further information, please visit the event website here
Live Webinar: RIM Maturity Model: A strategic path to next-generation Regulatory Information Management
Time: 10:30 – 11:30 EST
RIM has emerged as a way to provide reliable, reusable, and submittable product and regulatory information. Getting to next-generation RIM requires methodical maturity that plans implemental program improvement over 5 dimensions:
- Process
- Governance
- Data
- Technology
- Culture
Presenters:
Tom Beatty, Senior Managing Consultant, Navitas Life Sciences
Marty Boom, Global Head of Regulatory and Safety, Navitas Life Sciences
To register for this webinar, please click here.
Oracle Health Sciences: Safety Focus Group Meeting
Venue: Utrecht, The Netherlands
This meeting will see Oracle Health Sciences strategists and solution experts meet to explore Oracle Health Sciences Empirica product updates and discuss current pharmacovigilance hot topics. The event will look at how Artificial Intelligence will revolutionise case processing in the coming years, the latest in drug safety regulations, as well as looking at the benefits of moving to the cloud.
Navitas Life Sciences’ Marty Boom and Raj Srinivasan will be in attendance at this event.
For further information please visit the event website by clicking here
If you would like to arrange to meet with a member of our team please contact marketing@navitaslifesciences.com
Sparta Systems and Navitas Life Sciences Webinar – RIM made easy with TrackWise and idmpREADY
Time: 09:00 EDT
Presented by Sparta Systems’ Brandon Henning and Navitas Life Sciences’ Tom Beatty, this webinar will provide an overview of the FDA Guidance for the recent IDMP regulation, and explain how pharmaceutical companies should prepare and build a solution to meet the IDMP specifications that are connected to the TrackWise system.
idmpREADY, combines Navitas Life Sciences’ data management technologies to capture, record, publish, and maintain IDMP data points, together with Sparta Systems’ TrackWise QualityConnect framework to define, track, exchange, and report IDMP core processes.
Join us to explore:
- FDA and ISO requirements for IDMP
- A solution to meet the new IDMP regulations, including IDMP Submission and eCTD
- Document Management using pharmaREADY and idmpREADY software solutions
Live Webinar: The building blocks of successful outcomes in Data-Driven Clinical Trials
Time: 11:00am EST
With an estimated R&D cost of $2.5 billion for a drug to reach the market, sponsor companies face increasing pressure to complete clinical trials within time and budget. Updated regulations should accelerate adoption of technology and process / role changes that will enhance operational efficiency, quality and patient safety.
Sponsors are making key changes that include adopting a quality management and risk-based approach, improved data integrity and analysis, operating model and governance model redesign, risk based monitoring, redefined roles and responsibilities (RACI) translating to a robust set of SOP updates and outcomes.
Ensuring First Time Right submissions with regulators require the development, management and near real-time analysis of data that supports the desired trial outcomes across all phases of studies. Join us to learn how companies can achieve successful outcomes through streamlined technologies that enable proactive quality and improved outcomes.
Presenters:
Dr Krishnan Rajagopalan, Chief Growth Officer, Navitas Life Sciences
Dawne Nanda, Senior Managing Consultant, Navitas Life Sciences
To register for this webinar please click here.
Sidley pvlegal Forum
Venue: Celgene Offices, Summit, NJ, USA
Hosted by Celgene, the Sidley pvlegal Forum is an interactive meeting which will include presentations on global regulatory and litigation developments, benchmarking trends, and practical case studies on industry issues. Navitas Life Sciences’ Wilfred Gilich will be in attendance at this meeting.
For further information please visit the pvlegal website here or contact a member of the team at pvlegal@sidley.com
pvlegal is a specialized forum for in-house counsel and compliance personnel working on drug and device safety issues in the Life Sciences sector. Sidley Austin LLP serves as counsel to pvlegal. Additional support and sponsorship is provided by Navitas Life Sciences.
Webinar: Is labeling the next area ripe for outsourcing?
Time: 10:30am EST
As internal labeling processes become more mature and better defined, and labeling operations more efficient and value-driven, companies are turning their attention towards the potential of outsourcing to maximize strategic value.
This webinar explores where there are outsourcing opportunities in the labeling process and key considerations to help ensure that favorable outcomes are achieved.
Speakers:
Dr Denis Fung, Head of Regulatory and labelnet lead, Navitas Life Sciences
Zuby Okemefuna, Senior Consultant, Navitas Life Sciences
To register for this webinar please click here.
DIA 2018 Global Annual Meeting
Venue: Boston Convention and Exhibition Center, Boston, USA
The DIA 2018 Global Annual Meeting will bring together thousands of innovators from across the globe. The event is designed to drive insights into action by connecting key policy discussions to real-world knowledge. Sessions will include distinguished speakers and expert panellists from regulatory, industry, patient advocacy, and academia.
Navitas Life Sciences are delighted to be exhibiting at this event. Meet with us at booth 2641 to discover how you can transform your Clinical Trials through our insight driven Clinical, Regulatory, and Safety solutions that are customized to address your critical challenges. To schedule a meeting with one of our Subject Matter Experts, please click here.
For further information, please visit the event website here.
labelnet Forum - Spring
Venue: New York, USA
Established in 2011, labelnet is a network for labelling professionals, focused on the full lifecycle of labelling. The network provides a neutral platform for Heads of Labelling and Labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media)
Our June forum agenda is themed around ‘Labelling to the next level’ and will focus on the following:
- Regulatory update:
- GVP Module IX – updates and learnings so far
- EudraVigilance lessons learned
- Future ready labeling
- Next generation Medical Governance – CMO viewpoint
- Patient focus labeling – moving forward
- E-labeling - myth or future reality?
- Sourcing and resource models – today and tomorrow
- Labeling scorecard now and in the future
- Why measure? What to measure and how? Early development, operational, and strategic
pvconnect Forum - Spring
Venue: New York, USA
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life sciences companies with general portfolios or a specific focus. The network provides a neutral platform for Pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
Our June agenda is themed around ‘Smart solutions in a complex world’ and will focus on the following:
- The latest PV context
- Regulatory update
- RoW regulations
- CT monitoring
- Brexit
- Regulatory update
- Inspection Readiness in a shifting global context
- Smart solutions to everyday complexities
pvtech Forum - Spring
Venue: New York, USA
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enable and supporting PV technologies in their organisations. Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.
Our June agenda is themed around Automation & modern PV analytics and will focus on the following:
- PV tools and systems
- Automation opportunities
- Working Group update
- New sources of data
- Changing landscape PV analytics
- Opportunities of RWD, EHR
- PV digital roadmap
rimnet Forum - Spring
Venue: New York, USA
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented networks; pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM. Established in 2014, the roundtable has since become a full network focusing on global RIM implementation – enabling members to discuss the organisation, process and technology aspects of implementing a RIM governance framework and the challenges of achieving RIM data quality.
Our June forum agenda is themed around ‘The journey to RIM maturity’ and will focus on the following:
- Brexit impact and the level of preparedness
- E2E RIM (value for business and RIM business case)
- RIM Quality metrics and KPIs
- What is RIM data?
- RIM Technology
pvnet Summit - Spring
Venue: New York, USA
Established in 2001, pvnet is a network for Heads of Safety of Top 30 life sciences companies and invests in thought leadership to help to shape future practices. The network provides a neutral platform for Pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
Our June agenda is themed around ‘PV strategies...explored’ and will focus on the following:
- The latest PV context
- Regulations and EudraVigilance review
- Benchmark insights
- PV Value – the role of automation
- New approaches to value
- Automation as an enabler
- Impact on resources/talent
- The road ahead
labelnet Forum - Spring
Venue: London, UK
Established in 2011, labelnet is a network for labelling professionals, focused on the full lifecycle of labelling. The network provides a neutral platform for Heads of Labelling and Labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media)
Our June forum agenda is themed around ‘Labelling to the next level’ and will focus on the following:
- Regulatory update:
- GVP Module IX – updates and learnings so far
- EudraVigilance lessons learned
- Future ready labeling
- Next generation Medical Governance – CMO viewpoint
- Patient focus labeling – moving forward
- E-labeling - myth or future reality?
- Sourcing and resource models – today and tomorrow
- Labeling scorecard now and in the future
- Why measure? What to measure and how? Early development, operational, and strategic
pvtech Forum - Spring
Venue: London, UK
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enable and supporting PV technologies in their organisations. Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.
Our June agenda is themed around Automation & modern PV analytics and will focus on the following:
- PV tools and systems
- Automation opportunities
- Working Group update
- New sources of data
- Changing landscape PV analytics
- Opportunities of RWD, EHR
- PV digital roadmap
pvnet Summit - Spring
Venue: London, UK
Established in 2001, pvnet is a network for Heads of Safety of Top 30 life sciences companies and invests in thought leadership to help to shape future practices. The network provides a neutral platform for Pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
Our June agenda is themed around ‘PV strategies...explored’ and will focus on the following:
- The latest PV context
- Regulations and EudraVigilance review
- Benchmark insights
- PV Value – the role of automation
- New approaches to value
- Automation as an enabler
- Impact on resources/talent
- The road ahead
pvconnect Forum - Spring
Venue: London, UK
Established in 2006, pvconnect is a network for Heads of Safety of mid-sized life sciences companies with general portfolios or a specific focus. The network provides a neutral platform for Pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
Our June agenda is themed around ‘Smart solutions in a complex world’ and will focus on the following:
- The latest PV context
- Regulatory update
- RoW regulations
- CT monitoring
- Brexit
- Regulatory update
- Inspection Readiness in a shifting global context
- Smart solutions to everyday complexities
rimnet Forum - Spring
Venue: London, UK
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented networks; pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM. Established in 2014, the roundtable has since become a full network focusing on global RIM implementation – enabling members to discuss the organisation, process and technology aspects of implementing a RIM governance framework and the challenges of achieving RIM data quality.
Our June forum agenda is themed around ‘The journey to RIM maturity’ and will focus on the following:
- Brexit impact and the level of preparedness
- E2E RIM (value for business and RIM business case)
- RIM Quality metrics and KPIs
- What is RIM data?
Ensuring regulatory outcomes through NextGen regulatory operations
Time: 15:30 – 16:30 (BST) | 16:30 – 17:30 (CEST) | 10:30 – 11:30 (EST)
Presented by Navitas Life Sciences’ Marty Boom and Denis Fung this webinar will look at the changing expectations that Regulators, and also Business Partners, have for Regulatory Affairs organisations. The core deliverables of a Regulatory organisation are still omnipresent but, in addition, we expect global integration, lowered costs, compliance, and oversight across different jurisdictions and across different, disparate processes, systems, and organisational entities. Unless we rethink how our Regulatory organisation in all its facets need to function, we will not be able to keep delivering the high quality output that Regulators and our Business Partners are demanding. Using Labeling as an example, we will provide you with a view on how a next generation Regulatory organisation can adapt to the paradigm. Join us to explore:
- What are the key drivers for change in Regulatory?
- What are the challenges?
- How can we stay compliant, improve operational efficiency, and create value?
- Our model for success for the NextGen Regulatory Operations
For further information please contact networks@navitaslifesciences.com
Navitas Life Sciences at the Outsourcing in Clinical Trials Conference
Venue: Barcelona, Spain
Navitas Life Sciences, an integrated provider with CRO, regulatory, safety, technology and benchmark services to global life sciences industry will be speaking to Life Science professionals at the May 15 – 16 Outsourcing in Clinical Trials conference in Barcelona, Spain. Navitas Life Sciences will also host an evening reception at the conference. The conference will attract life science industry professionals from the majority of the world’s largest pharmaceutical and biotech companies.
Navitas’ subject matter experts and senior management will be on hand to speak to industry professionals about current clinical trial trends, best practices on partnership models and other key topics. For more information, visit http://www.arena-international.com/octeurope/
OPPI Medical Forum Meeting
Venue: The St. Regis, Mumbai, India
Navitas Life Sciences will be exhibiting at OPPI (Organisation of Pharmaceutical Producers of India) The forum will provide operational and hands on discussion on the important updates that impact work across the different functions in medical (Medical Affairs , Clinical Research, Regulatory and Pharmacovigilance) to lead to better cross functional alignment for improved favorable outcomes in day to day function.
This platform will provide access to a captive audience of medical affairs personnel of most of OPPI member companies. The platform provides influence, through face-to-face opportunities to engage in dialogue with prospective clients and decision makers.
eRegulatory Summit
Venue: SANA Lisboa Hotel, Lisbon, Portugal
Navitas Life Sciences are sponsoring the eRegulatory Summit. The event is focused on RIM, eCTD, IDMP and TMF.
On Wednesday 25 April between 12:25 – 12:55 Navitas’ Managing Director, Marty Boom, will be presenting a session titled: ‘Ensuring regulatory outcomes through NextGen regulatory operations’
For further information about the conference, please visit the event website at: https://lifesciences.knect365.com/eregulatory-summit/
If you would like to arrange to meet with a member of our team please contact marketing@navitaslifesciences.com
DIA Global Labeling Conference
Venue: Bethesda, Maryland
Navitas Life Sciences will be at the DIA Global Labeling Conference in Bethesda, Maryland on April 24th and 25th. The conference will attract labeling and clinical safety professionals from some of the world’s largest pharmaceutical and biotech companies.
Navitas’ subject matter experts will be on hand to speak about the challenges of the end-to-end labeling and artwork management process. This one of the most difficult business processes for any life science company to manage effectively. The process typically spans the three primary divisions of any life science company – Commercial, Research and Supply Chain. World class processes and governance do not develop organically – they require a clear strategy, rigorous process design and discipline, and effective cross divisional governance. Navitas Life Sciences is an experienced strategic partner in labeling and artwork management. We have more than a decade of experience in Enterprise Labeling Process re-engineering and have team members who have played industry leadership roles in Structured Product Labeling and related data standards. In addition, we have access to a pool of talent in our Chennai Center of Excellence as well as our Central American hub in Columbia to provide cost effective labeling coordination and proof reading expertise.
Oracle Industry Connect 2018
Venue: Hilton Midtown, New York
Oracle Industry Connect is a two-day conference where industry peers join together to share deep-domain expertise and best practices on the mission-critical applications that are core to their businesses. Ninety percent of the breakout session content is comprised of Oracle customers providing insights on identifying and overcoming complex industry challenges.
The invitation-only event showcases:
- A community of distinguished industry thought leaders
- Exclusive networking opportunities
- Examples of cross-industry collaboration
For further information please visit the event website: https://www.oracle.com/oracleindustryconnect/index.html
If you would like to arrange to meet with a member of the Navitas Life Sciences team please contact marketing@navitaslifesciences.com
Webinar: Learn how companies are transforming clinical operations in light of ICH E6 (R2)
Time: 11:00 – 12:00 EST
This webinar will be co-presented by the Quality Consortium – The Avoca Group and Navitas Life Sciences and will discuss the transformations that are being made in clinical operations in order to address the requirements of ICH E6 (R2).
Presenters
Hershell Thompson- Senior Managing Consultant, Navitas Life Sciences
Dr. Janet Fernihough – Senior Consultant, Navitas Life Sciences
Dr. Cristin MacDonald – Executive Director Client Delivery, The Avoca Group
Key Takeaways
- Gain insight into how companies are modifying their standard practices to reach ICH E6 (R2) compliance
- Learn key challenge organizations face in modifying current processes for ICH E6 (R2) compliance
- Learn positive steps organizations have taken to adapt current practices to be compliant with the regulations
To register to attend please click here
pvindia Forum - Spring
Venue: Mumbai, India
Following the successful launch of pvindia in 2016, we are delighted to be hosting our fifth event this year.
pvindia is our network for regional PV leads of life science companies with pharma, consumer, generic, or mixed portfolios within the Asia Pacific region.
Our March meeting will look at the PV Change Journey. The agenda will look at:
- Introductions and the latest PV context
- Roundtable discussion – recent achievements and forthcoming challenges
- A regulatory perspective, the latest from the FDA , EMA and ROW
- Other drivers for PV change and growth
- PvPI revisited – check in and lesson learnt so far
- Reflections on PvGI implementation – to date
- A view from PvPI, and an industry perspective on experiences so far
- E2B (R3) – expectation vs reality and where next?
- Temperature check on the reality of E2B(R3) and where next
- Pushing technology to the next level – Apps, automation and beyond
- Managing PV change and growth
- Navigating PV change in an M&A situation
- How PV Partners and vendors are changing the PV landscape – for good and bad
- Community next steps
- Roadmap of dates, hot topics, new tools/ways to interact as a community
Join Navitas Life Sciences at the 2nd European Clinical Quality Oversight Forum
Venue: London, UK
Dr. Janet Fernihough, MBA from Navitas Lifesciences, will lead the panel “ICH E6 R2 Compliance, Reflecting on the Actions and Process Adjustments Taken to Achieve ICH E6 R2 Compliance”. The panel includes Siobhan Hurley from Abbvie, Bodo Lutz from Novartis, Celeste Gonzalez from Boston Scientific, and Karen Hue from Aimmune Therapeutics. The panel discussion will:
- Examine how operations were assessed to determine where adjustments needed to be made to ensure compliance
- Conceptualize action plans and align responsibilities
- Evaluate the challenges and obstacles and how they were overcome
- Discuss lessons learned and what could have been done better
The session will take place at 3pm, February 27th, at the Radisson Blu Portman Hotel in London. For more information, click here
Navitas Networks Live Webinar on: EudraVigilance - Handling the far reaching and diverse impact on changes to EV system
Time: 15:30 – 16:30 GMT/ 10:30 – 11:30 EST
Agenda:
- The New EV System
- Setting the context
- Review the key elements of EV System
- Temperature check on EV Changes
- E2B(R3) implementation - Impact to exiting processes
- EVDAS Changes
- Summary
- Key challenges
- Lessons learnt
- Q & A, Close
To register for this event, please click
pvlegal Biannual Meeting
Venue: Astellas Offices, Leiden, The Netherlands
Join your life sciences peers for topical conversation, learning and networking at a meeting focused on the legal aspects of pharmacovigilance.
This interactive meeting will include presentations on:
- The Impact of Brexit on Pharmacovigilance
- What’s Next: Class Action Lawsuits in the EU
- PV and the New EU Data Protection Rules
- Impact of EudraVigilance Reporting Changes on PV Agreements
What is pvlegal?
pvlegal is a membership based forum for in-house counsel and compliance personnel at pharmaceutical companies working on pharmacovigilance issues. This is supported by regular benchmarking of member performance and best practice sharing in the area or drug safety. For further information please visit: http://pvlegal.navitas.net/
Navitas Networks Live Webinar on: EudraVigilance - Handling the far reaching and diverse impact on changes to EV system
Time: 10:30 – 11:30 GMT/ 16:00 - 17:00 IST
Agenda:
- The New EV System
- Setting the context
- Review the key elements of EV System
- Temperature check on EV Changes
- E2B(R3) implementation - Impact to exiting processes
- EVDAS Changes
- Summary
- Key challenges
- Lessons learnt
- Q & A, Close
Registration page link: http://inform.navitaslifesciences.com/af2?LinkID=CH00097058eR00000253A
ISCR Annual Meeting
Venue: Bangalore, India
Navitas’ experts will be on hand to speak about full service clinical offerings that deliver transformational outcomes across Phase II – IV clinical trials, non – interventional studies, and biologics & biosimilars studies at ISCR’s annual meeting on 19th & 20th January in Bangalore, India. We will also demo OneClinical, our next generation clinical trials management platform at this event. To arrange a meeting, please contact marketing@navitaslifesciences.com.
Navitas & AbbVie ring in the New Year with the Rise of MRP/PSPs Webinar
Time: 15:30 – 17:00 GMT
Navitas rings in 2018 with “Managing PSPs”, a webinar that explores the rise of MRP/PSPs, a key area of focus for many pharmaceutical companies, and an element of the data explosion that is sweeping across the life sciences industry. The webinar will investigate the challenges associated with PSPs as well as opening a discussion on the potential opportunities for companies, looking at areas such as:
- PV involvement in PSP design and approval
- Training vendors on PSPs
- Taking a risk-based approach to PSPs
- Technologies for managing PSPs
Kimberly Kotlar, Director, Organized Data Collection Center of Excellence will provide a case study relating to Abbvie’s experience with PSPs/MRPs.
To register for the webinar, click here
Live Webinar: GVP Module IX update – Impact beyond borders
Time: 15:30 – 17:00 GMT
Agenda:
- GVP Module IX - Signal Management (Revision 1)
- A quick overview
- What's new in the latest update?
- Impact beyond borders
- What does this mean for PV and Signal Management?
- How will this affect RA, labeling, and beyond?
- Model for success: process, governance, tools
- Summary
- Top tips for success
Live Webinar: BA/BE Studies Best Practices – Gaining the First to File Advantage
Time: 1100 EST /1600 UK Time
On 7th December, join Navitas Life Sciences’ Bioavailability and Bioequivalence experts, Dr Ayaaz Hussain Khan and Dr Raghavendra Shetty, to understand how you can ensure quality and compliance, while reducing time to market and cost. In this webinar, you will learn to leverage industry best practices and the latest technology to adhere to constantly changing regulatory requirements, improve efficiencies, and get a competitive edge.
Navitas Networks Webinar: GVP Module IX update – Impact beyond borders
Time: 115:30 – 17:00 GMT
Agenda:
- GVP Module IX - Signal Management (Revision 1)
- A quick overview
- What's new in the latest update?
- Impact beyond borders
- What does this mean for PV and Signal Management?
- How will this affect RA, labeling, and beyond?
- Model for success: process, governance, tools
- Summary
- Top tips for success
Partnerships in Clinical Trials Europe
Venue: Amsterdam RAI Exhibition and Convention Center – Stand 87
Navitas Life Sciences will be at stand 87 at the Partnerships in Clinical Trials Europe Conference in Amsterdam on November 28th & 29th. The conference will attract over 1,000 industry professionals from over 450 companies.
Navitas’ subject matter experts will be on hand to speak about full-service offerings that deliver transformational outcomes across Phase I – IV Clinical Trials, Consulting Services (including ICH E6 compliance), Non – Interventional Studies and, and Clinical Data Management. Information on our services across Regulatory, Pharmacovigilance and Safety will also be available at the stand.
pvconnect Forum - Autumn
Venue: New York
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
Focussing on themes in building a borderless, networked PV ecosystem
- The latest regulatory context, discussion of implementation challenges and sharing of solutions
- Managing the impact of growth and change on PV – challenges and opportunities during M&A, co-MAH agreements, divestment, expansion into new geographies
- Maintaining oversight and alignment across a 360 degree PV organisation that includes HQ, Affiliates, Partners and Vendors
- Open agenda space for facilitated discussion with peers of topics that are top of your mind on the day
For further information or to register to attend please contact pvconnect@navitaslifesciences.com
labelnet Forum - Autumn
Venue: New York
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
- Strategic labeling:
- Patient centric labeling: Speed to get information to patients including e-labeling
- Operational labeling:
- Managing interfaces: global, local, partners - struggle in aligning different cultures, people, regulations, in global companies
- Affiliate perspectives on labeling: E2E tracking and impact on affiliates workload
- Managing the back-end of the labeling process: Labeling implementation after HA approval; Serialization
For further information or to register to attend please contact labelnet@navitaslifesciences.com
pvtech Forum - Autumn
Venue: New York
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.
We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.
PV tools for today and getting fit for the future
- The latest context: EU (GDPR) update, Brexit and the QPPV, Benchmark insights
- Exploration of PV compliance monitoring tools
- PV ecosystem applications and SDB integration approaches
- A temperature check on EudraVigilance / E2B(R3) implementations
- PV ecosystem and scanning applications around the safety database
- Clinical to safety – integrating the clinical systems with the safety database
- Update from our Automation Working Group and kick-off for Digital WG
rimnet Forum - Autumn
Venue: New York
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.
This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.
- Implementing a RIM Governance framework
- The challenges of achieving RIM data quality
For further information or to register to attend please contact rimnet@navitaslifesciences.com
pvnet Summit – Autumn
Venue: New York
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
The Autumn agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.
Focussing on themes in PV transformation and how to engage the patient
- Update on the latest external context in regulations and the life science industry
- The agenda and next steps for PV transformation teams at the convergence of technological, regulatory and industry change
- Engaging the patient in PV as ways of communicating change and medicine becomes increasingly personalised around outcomes focussed wellbeing plans
For further information or to register to attend please contact pvnet@navitaslifesciences.com
pvconnect Forum - Autumn
Venue: London
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
Focussing on themes in building a borderless, networked PV ecosystem
- The latest regulatory context, discussion of implementation challenges and sharing of solutions
- Managing the impact of growth and change on PV – challenges and opportunities during M&A, co-MAH agreements, divestment, expansion into new geographies
- Maintaining oversight and alignment across a 360 degree PV organisation that includes HQ, Affiliates, Partners and Vendors
- Open agenda space for facilitated discussion with peers of topics that are top of your mind on the day
For further information or to register to attend please contact pvconnect@navitaslifesciences.com
labelnet Forum - Autumn
Venue: London
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
- Strategic labeling:
- Patient centric labeling: Speed to get information to patients including e-labeling
- Operational labeling:
- Managing interfaces: global, local, partners - struggle in aligning different cultures, people, regulations, in global companies
- Affiliate perspectives on labeling: E2E tracking and impact on affiliates workload
- Managing the back-end of the labeling process: Labeling implementation after HA approval; Serialization
For further information or to register to attend please contact labelnet@navitaslifesciences.com
pvtech Forum - Autumn
Venue: London
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.
We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.
PV tools for today and getting fit for the future
- The latest context: EU (GDPR) update, Brexit and the QPPV, Benchmark insights
- Exploration of PV compliance monitoring tools
- PV ecosystem applications and SDB integration approaches
- A temperature check on EudraVigilance / E2B(R3) implementations
- PV ecosystem and scanning applications around the safety database
- Clinical to safety – integrating the clinical systems with the safety database
- Update from our Automation Working Group and kick-off for Digital WG
pvnet Summit – Autumn
Venue: London
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
The Autumn agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.
Focussing on themes in PV transformation and how to engage the patient
- Update on the latest external context in regulations and the life science industry
- The agenda and next steps for PV transformation teams at the convergence of technological, regulatory and industry change
- Engaging the patient in PV as ways of communicating change and medicine becomes increasingly personalised around outcomes focussed wellbeing plans
For further information or to register to attend please contact pvnet@navitaslifesciences.com
rimnet Forum - Autumn
Venue: London
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.
This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.
- Implementing a RIM Governance framework
- The challenges of achieving RIM data quality
For further information or to register to attend please contact rimnet@navitaslifesciences.com
CPhI Worldwide
Venue: Messe Frankfurt, Germany / Stand No: 41M13
Navitas Life Sciences will be at stand 41N04 in Hall 4.1 in the CPhI Worldwide Conference, Frankfurt, Germany. The conference, held from October 24th to 26th, will witness the participation of over 42,000 pharmaceutical professionals from 153 countries.
Navitas’ subject matter experts will be on hand to speak about our full-service offerings that deliver transformational outcomes across Phase I – IV Clinical Trials, Consulting Services (including ICH E6 compliance), Non – Interventional Studies, BA/BE Studies, and Clinical Data Management. Information on our services across Regulatory, Pharmacovigilance and Safety will also be available at the stand.
Stand 41N04 is located in the CRO & Clinical Trials Gold Zone in in Hall 4.1. For more information or to arrange a meeting at the conference, contact us at contact@navitaslifesciences.com
pvindia Forum – Autumn
Venue: ITC Maratha, Mumbai
Following the successful launch of pvindia in 2016, we are delighted to be hosting our fourth event this year. pvindia, is our network dedicated to bringing together PV Global/Regional Heads of PV and PV Leadership teams in the APAC region.
What topics will the forum cover?
- Latest international regulatory context: FDA, EMA, progress check on E2B(R3) and lessons learnt so far
- Future automated PV process landscape and latest view of the pvtech community benchmarks
- PvGI latest news and implementation update
Navitas Networks Webinar: RIM Maturity Pathway – achieving your RIM goals using the RIM Maturity Model
Time: 15:30 – 17:00 GMT
Hosted by Navitas Networks this webinar is presented by Gary Aldam, Senior Consultant, Navitas Life Sciences & Richard Petherick, Client Partner and rimnet Lead, Navitas Life Sciences
Agenda:
- Understand the RIM Maturity model dimensions
- Understand how to use the maturity model to plan future investment
- Understand the need to manage stakeholders and build the business case for change
Navitas webinar series on ICH E6 GCP compliance
2nd webinar of this series: Adopting the new ICH E6 GCP regulations impacts clinical trial outcomes positively
Time: 15:30 UK / 16:30 CET / 10:30 EST / 7:30 PST / 20:00 IST
Agenda:
- Regulatory drivers
- Where does RBM fit into the overall ICH E6 changes
- Risk control and the value of Quality Tolerance Limits
- The extent and nature of monitoring
- Industry status on implementation of new regulations and next steps
Navitas Networks Webinar on: The safety database in a pharma company – tactical considerations for delivering on compliance and efficiency
Time: 11:30am -13:00pm GMT | 4:00pm to 5:00pm IST
We are pleased to announce the next Navitas Networks Webinar is taking place on 14th September & will be presented by Mayank Raizada from Navitas Life Sciences
Agenda:
- Regulatory impacts on the safety database
- Increasing efficiency in case processing by utilising functionalities and interfaces
- Handling market complexities
- Dilemmas for using the safety database for aggregate reporting and analytics
Navitas Networks Webinar On: Labeling Organization – Simplicity or Specialism?
Time: 15:30 – 17:00 GMT
We are pleased to announce the next Navitas Networks Webinar is taking place on 13th September & will be presented by Denis Fung from Navitas Life Sciences.
Agenda:
- The evolving labeling organisation
- Key requirements
- Simplicity or Specialism?
- Organizing your Global Labeling Function
- Building a more effective Global Labeling function
- What is the best fit for your company?
- So what and where next?
- Key pain points
- What is the optimal structure?
- Q & A, Close
Navitas Networks Webinar on: End to End Labeling Technologies - Looking Forward
Time: 15:30 – 17:00 GMT
We are pleased to announce the next Navitas Networks Webinar is taking place on August 30th & will be presented by Govind Srinivasan, Jim Chesterman, Zuby Okemefuna & Midhun Kiriyan from Navitas Life Sciences.
Agenda:
- Introduction
- Overview of End-to-End (E2E) Labelling Technologies and Current Industry Challenges
- What possibilities exist for E2E Label Tracking?
- Manual, system assisted tracking
- Loosely coupled, integrated system
- Fully integrated system
- Looking towards the future
- How can Navitas help you move forward?
- Our related services
- Q&A
Navitas webinar series on ICH E6 GCP compliance
1st webinar of the series: Impact of ICH E.6 addendum on Quality for Sponsors (or Quality by Design in Clinical development)
Time: 15:30 UK / 16:30 CET / 10:30 EST / 7:30 PST / 20:00 IST
Presented by Andy Lawton, Consultant and Director of Risk Based Approach Ltd and Janet Fernihough, Senior Consultant at Navitas Life Sciences.
Agenda:
- What is Quality by Design?
- Regulatory perspective
- Drivers for quality in the pharmaceutical industry
- What can we learn about Quality by design from the manufacturing industry?
- The importance of design, control and improve.
- Application at the project and trial level
- Applying Quality by Design learning in manufacturing to clinical trial management
- Risk assessments
- Quality tolerance limits
- Continuous process improvement
For further information please email networks@navitaslifesciences.com
Navitas networks webinar On: The safety database in a pharma company – tactical considerations for delivering on compliance and efficiency
Time: 15:30 – 17:00 GMT
We are pleased to announce the next Navitas Networks Webinar is taking place on 20th July & will be presented by Martin Holms-Petersen, Senior Consultant and Head of pvtech Navitas Life Sciences.
Agenda:
- Regulatory impacts on the safety database
- Increasing efficiency in case processing by utilising functionalities and interfaces
- Handling market complexities
- Dilemmas for using the safety database for aggregate reporting and analytics
- Looking forward
DIA 2017 Annual Meeting
Venue: Chicago, IL
Navitas presents at DIA Annual Meeting in Chicago.
Principal Consultant Jeffrey Ho will present “Successes and Challenges in Achieving and Maintaining Oversight of Pharmacovigilance Affiliates” at DIA’s annual meeting in Chicago, IL at 10:30am on June 21st.
Jeffrey is part of a panel session titled “The Brave New World: The Ongoing Globalization of Pharmacovigilance”. Additional panelists include the Global Head of Pharmacovigilance and Medical Affairs from Otsuka Pharmaceuticals.
For more information on the sessions, click here.
To arrange a meeting with Navitas pharmacovigilance experts, click here.
pvconnect forum spring London
Venue: London
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
Agenda topics for Spring 2017 will include the need to balance compliance with agility; our London forum will be centred on QPPV-related discussions.
For further information or to register to attend please contact pvconnect@navitaslifesciences.com
pvtech Forum - Spring
Venue: London
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.
We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.
For further information or to register to attend please contact pvtech@navitaslifesciences.com
pvtech Forum - Spring
Venue: New York
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance.
We will be looking at how to increase business value from PV technology investments, as well as delivering new insights and new methods of handling the ever increasing work load, requirements and complexities.
For further information or to register to attend please contact pvtech@navitaslifesciences.com
rimnet Forum - Spring
Venue: New York
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.
This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.
For further information or to register to attend please contactrimnet@navitaslifesciences.com
pvnet Strategic Summit - Spring
Venue: New York
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
The Spring agenda will focus on implementation of innovation ideas, with a focus on the role of technology and new sources of data.
For further information or to register to attend please contact pvnet@navitaslifesciences.com
pvconnect Forum - Spring
Venue: New York
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
Agenda topics for Spring 2017 will include the need to balance compliance with agility; our London forum will be centred on QPPV-related discussions.
For further information or to register to attend please contact pvconnect@navitaslifesciences.com
labelnet Forum - Spring
Venue: New York
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
The Spring agenda will focus on smart labeling and will include smart strategy (development labeling and local intelligence), smart resources (outsourcing and key labeling roles) and smart management (labeling across sectors and back end of the E2E process) and smart technology (one day technology showcase on labeling and RIM key tools and systems (in London only)
For further information or to register to attend please contact labelnet@navitaslifesciences.com
cmonet strategic summit
Venue: New York
cmonet was launched in 2014 and since then twenty CMOs from a range of large and medium pharmas and biotechs have participated. Fifteen CMOs completed a survey on the evolving role of the CMO. Three face-to-face meetings have taken place with member-led agendas relating to challenges in common and the evolving context.
For more information please contact cmonet@navitaslifesciences.com
CPhI’s 2nd Annual CAPA & Root Cause Investigation Workshop
Venue: Mumbai
Navitas along with Sparta Systems is exhibiting at CAPA & Root Cause Investigation Workshop. CPhI’s CAPA & Root Cause Investigation Workshop is the only forum in India dedicated to identifying non-compliance, understanding the root cause, and responding with appropriate corrective and preventive actions for the Pharmaceutical companies. It is an exclusive workshop mentored by Former USFDA Director on areas of quality and manufacturing in Pharma companies with focus on USFDA’s Quality System Guide, recent Warning Letters and EU-GMP Chapter 1 regulations.
If you would like further information, please contact us at: contact@navitaslifesciences.com
Webinar - FDA’s Requirements for eCTD Submissions
Time: 2 PM EST
Webinar will cover:
- New regulatory requirements – and their advantage
- Organizational challenges
- How to prepare – quickly – for submitting applications electronically
- Document granularity considerations
- What to do with legacy documents
- Document templates – not optional
- How to use the FDA’s Gateway and more
For further information please email contact@navitaslifesciences.com
rimnet Forum - Spring
Venue: London
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.
This forum is now a full network focusing on global RIM implementation to provide a platform to discuss organisation, process and technology aspects.
For further information or to register to attend please contactrimnet@navitaslifesciences.com
labelnet Forum - Spring
Venue: London
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
The Spring agenda will focus on smart labeling and will include smart strategy (development labeling and local intelligence), smart resources (outsourcing and key labeling roles) and smart management (labeling across sectors and back end of the E2E process) and smart technology (one day technology showcase on labeling and RIM key tools and systems (in London only)
For further information or to register to attend please contact labelnet@navitaslifesciences.com
Webinar hosted by Navitas Networks: Evolving IDMP Guidelines
Time: 15:30 – 17:00 GMT
We are pleased to announce the next Navitas Networks Webinar is taking place on 8th May & will be presented by Gary Aldam and Mayank Raizada
Agenda:
- The evolving IDMP guidelines
- Key requirements
- Expected timelines
- What it means in reality?
- 5 steps to IDMP readiness – a pyramid for success
- Data management
- Governance, Organisation
- Process and Technology
- So what and where next?
- Benefit or burden?
- Where will it lead?
- Q & A, Close
For further information please contact networks@navitaslifesciences.com
Webinar hosted by Navitas Networks: Transitioning into a new era of Risk Management in Europe
Time: 15:30-17:00 GMT
Agenda:
- Update on Risk Management in Europe
- Overview of RM in EU
- Summary of GVP V and VXI changes
- Practical application: What does it mean?
- Focus of the implementation taskforce
- Maintaining the EU norm through change
- Understanding the scientific shift in RM
- Transitioning to the revised template
- Updating the QMS
- Global impact
For further information please contact networks@navitaslifesciences.com
eRegulatory Summit
Venue: Hotel Meliá Avenida América, Madrid
Navitas will be exhibiting in upcoming eRegulatory Summit in Madrid which focuses on Connecting rim, IDMP and eCTD professionals to drive regulatory strategies through authority access and industry expertise.
Garry Aldam, Senior Consultant and David Gwyn, Head of Technology Practice at Navitas Life Sciences along with Michael Kline, Senior Solutions Consultant at Sparta Systems, will be speaking on topic “Addressing IDMP Requirements with Navitas and TrackWise – the system you most likely already have.” at 15:50, Apr 25
If you would like further information, please contact us at: contact@navitaslifesciences.com
Webinar hosted by Navitas Networks: PLLR – many questions, some answers
Time: 15:30 – 17:00 GMT
We are pleased to announce the next Navitas Networks Webinar is taking place on 24th April and will be presented by Denis Fung (Navitas), Suzette Hildebrand (Pfizer) and Ellen Wong (Allergan)
Agenda:
- The what and why of PLLR
- Why PLLR – context and story so far
- Review of Regulations 1 year on – reflections and impacts
- A Reflection of different company experiences
- Pfizer case study
- Allergan case study
- Discussion on challenges, lessons learnt and further questions to ponder
- Forward Look
- Summary of emerging Best practice
- Q&A Close
For further information please contact networks@navitaslifesciences.com
India - TrackWise User Group (TUG)
Venue: ITC Maratha, Mumbai
Navitas and Sparta Systems will host the 3rd TrackWise User Group (TUG) meeting on 19th April 2017 in Mumbai. The event is a platform for TrackWise users across India to connect and share their experiences and best practices. Users can also learn from experts on how to get more from their investments in TrackWise.
If you would like further information, or you would like to register to attend this meeting, please contact us at: contact@navitaslifesciences.com
Oracle Industry Connect Conference 2017
Venue: Orlando, Florida
Navitas Multi-Tenant Argus SafetyREADY™ Shared Cloud at Oracle’s Industry Connect Conference
Navitas will be highlighting the SafetyREADY Shared Cloud at the Oracle Industry Connect conference. Traditional deployments of Oracle Argus Safety have meant high implementation, infrastructure and maintenance costs that are prohibitive for many companies. Additionally, Oracle’s case based licensing model means that companies with low case volumes pay for volume that they will not use.
The SafetyREADY™ Shared Cloud utilizes the benefits for multi-tenant cloud sharing, which offers a cost-effective solution (saving more than 50%) for companies with smaller case volumes. Navitas invests in infrastructure and licensing on client’s behalf and reduces implementation costs by utilizing our pre-validated and pre-configured “gold instance”. The flexible costing model adapts to clients changing case volumes over time, clients only pay for what they need.
To learn more, visit Navitas at the Oracle Industry Connect conference in the Life Science pavilion.
If you would like further information, please contact us at: contact@navitaslifesciences.com
pvindia Forum - Spring
Venue: Mumbai, India
Following the successful launch of pvindia in 2016, we are delighted to be hosting our third event this year. pvindia, is our network dedicated to bringing together PV Global/Regional Heads of PV and PV Leadership teams in the APAC region.
- What topics will the forum cover?
- The latest PV Regulatory context – balancing global and local requirements
- Update on the global context: FDA, EMA latest PV regulations
- Deep dive and industry discussion on the proposed PvPI guidelines (building on previous discussion in October)
- An operational PV perspective, with case studies and discussions
How to move the community forward
HDA’s 2017 Distribution Management Conference and Expo
Venue: JW Marriott Desert Springs, Palm Desert, California, USA
Navitas will be demonstrating traceREADY in booth 108 at HDA’s 2017 Distribution Management Conference and Expo. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.
For further information, please visit the event website here or to schedule a demo please contact us at contact@navitaslifesciences.com
Webinar hosted by Navitas Networks: E2E labeling – Achieving Global Consistency
Time: 15:30 – 17:00 GMT
Hosted by Navitas Networks this webinar E2E labeling – Achieving Global Consistency will be presented by Tara Baer, one of our expert navigators here at Navitas.
Agenda:
- The Global labeling Context
- Trends, drivers, expanding horizons
- The need for a global approach
- Building Global connections
- Labelling – through the eyes of an affiliate / a global perspective
- The evolving Technology landscape – a global/local E2E view
- A practical experience
- Looking forward
- What is on the horizon?
To register please click here
For further information please contact networks@navitaslifesciences.com
Sidley pvlegal Biannual Meeting
Venue: ALK Abelló offices, Hørsholm, Denmark
Navitas’ Senior Consultant, Martin Holm-Petersen, will be attending this conference as a delegate.
This interactive meeting will include hot topics in drug and device safety reporting, panel discussions, benchmarking trends, and case studies.
pvlegal is a membership-based forum for in-house counsel and compliance personnel working on pharmacovigilance issues in the Life Sciences sector. This is supported by regular benchmarking of member performance and best practice sharing in the area of drug and device safety reporting. For more information about pvlegal please visit the network website here or contact a member of the pvlegal team at pvlegal@sidley.com or to arrange to meet with Martin please contact us at contact@navitaslifesciences.com
DIA’s Regulatory Submissions, Information, and Document Management Forum
Venue: Bethesda, Maryland, USA
Navitas will join life science executives from companies such as Amgen, Bristol-Myers Squibb, Pfizer, Teva, and more at DIA’s Regulatory Submissions, Information, and Document Management Forum in Bethesda, Maryland.
For further information please visit the event website here or contact us at contact@navitaslifesciences.com
Navitas and Sparta Systems - EQMS Webinar Series
Time: 11:00 am – 12:00 pm IST
1st Webinar of the Series - Ensuring Data Integrity, Mitigating Risk and Quality Metrics
This webinar will address the key challenges life sciences’ manufacturers face and the importance of:
- Managing quality processes, data and ‘metrics’ consistently and accurately
- A Quality Management System (QMS) with inherent analytical capabilities:
- Reduces audit time and findings
- Decreases risk of product recalls
- Enables better decisions faster without the high costs of implementing and maintaining an external business intelligence solution
Followed by hands-on live demo of TrackWise Solution.
To register please click here
For further information please contact contact@navitaslifesciences.com
Sidley Network Events: Inside The Minds of Regulators: Perspectives on Eu Pharmaceutical and Medical Devices Law
Venue: The Hotel Brussels, Belguim
Please join us for an inside look at how the latest legal and regulatory developments in EU law will affect companies operating in the life sciences space. We will bring together senior members of the European Commission and regulatory and business community to address the potential impact of new pharmaceutical and medical devices legislation and regulation. Sessions will cover medicinal products, including clinical trials, pharmacovigilance and orphan medicinal products, and medical and in vitro diagnostic devices, as well as competition law issues affecting the pharmaceutical sector. Our panelists/speakers will also discuss the foreseeable impact of Brexit on the life sciences industry.
To register please click here
For further information please contact contact@navitaslifesciences.com
Webinar Hosted by Navitas Networks: Medical Devices and Combination Products - Safety and Vigilance Requirements in the US and Europe
Time: 15:30-17:00 GMT
Hosted by Navitas Networks this webinar Medical Devices and Combination Products -Safety and Vigilance Requirements in the US and Europe will be presented by Navitas’ Managing Consultant Tido Eger.
Agenda:
- Introduction
- The need for device vigilance in pharma companies
- FDA’s oversight of combination products, new developments and safety concerns
- Practical experience with FDA Combination Product rules
- Questions & Answers
To register please click here
For further information please contact networks@navitaslifesciences.com
rimnet Forum
Venue: 09:30 – 16:30, New York
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact a member of our rimnet team at rimnet@navitaslifesciences.com
pvconnect Forum
Venue: 09:30 – 16:30, New York
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
For further information or to register your interest in participating at this meeting, please contact a member of our pvconnect team at pvconnect@navitaslifesciences.com
labelnet Forum
Venue: 09:30 – 16:3, New York
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
If you are interested in further information or to register your interest in participating, please contact a member of our labelnet team at labelnet@navitaslifesciences.com
pvtech Forum
Venue: 09:30 – 16:30, New York
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
If you are interested in further information or participating at this meeting, please contact a member of our pvtech team at pvtech@navitaslifesciences.com
Author-It Annual Summit for Life Sciences
Venue: Hilton Penn’s Landing, 201 S. Columbus Boulevard, Philadelphia, PA, USA
Navitas’ Head of Technology, David Gwyn, will be presenting a session at this conference titled ‘Leveraging Structured Content to Streamline End-to-End Labelling’. This session, taking place on Tuesday 15 November, will discuss a new era of utilising a centralised structured content repository for managing from the CCDS to regional labelling, the integration possible to ‘manage to clock’ necessary in end-to-end tracking, and the interaction with unstructured content
For further information please visit the event website here or to arrange to meet with David please contact us at contact@navitaslifesciences.com
pvnet Summit
Venue: 09:30 – 16:30, New York
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
For further information or to register your interest in participating at this meeting, please contact a member of our pvnet team at pvnet@navitaslifesciences.com
pvnet Summit
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
For further information or to register your interest in participating at this meeting, please contact a member of our pvnet team at pvnet@navitaslifesciences.com
HDA’s (Healthcare Distribution Association) 2016 Traceability Seminar
Venue: Renaissance Washington, DC Downtown Hotel, Washington, DC, USA
Navitas will be demonstrating traceREADY in booth 512 at PackExpo/PharmaExpo November 6-9 in Chicago, IL. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.
For further information please visit the event website here or to schedule a demo please contact us at contact@navitaslifesciences.com
pvtech Forum
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
For further information or to register your interest in participating at this meeting, please contact a member of our pvtech team at pvtech@navitaslifesciences.com
labelnet Forum
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
If you are interested in further information or to register your interest in participating, please contact a member of our labelnet team at labelnet@navitaslifesciences.com
rimnet Forum
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held twice a year since in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact a member of our rimnet team at rimnet@navitaslifesciences.com
pvconnect Forum
Venue: 09:30 – 16:30, Sidley Austin LLP Offices, London
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
For further information or to register your interest in participating at this meeting, please contact a member of our pvconnect team at pvconnect@navitaslifesciences.com
PackExpo/PharmaExpo
Venue: McCormick Center, Chicago, IL, USA
Navitas will be demonstrating traceREADY in booth 512 at PackExpo/PharmaExpo November 6-9 in Chicago, IL. traceREADY is Navitas’ Edge solution that enables DSCSA compliance. The DSCSA deadline is November 17th, 2017. traceREADY gets up and running quickly and has the lowest total cost of ownership in the marketplace. traceREADY is for Life Science companies that have to comply with DSCSA regulations including pharma/biotech manufacturers, third party logistics (3PL’s) companies and Pre-Manufacturing facilities.
For further information please visit the event website here or to schedule a demo please contact us at contact@navitaslifesciences.com
pvindia Forum
Venue: 09:30 – 16:00, The Hyatt Regency Hotel, Mumbai Sahar Airport, Ashok Nagar, Mumbai, Maharashtra 400099, India
Following the successful launch of pvindia in March this year, with participation from: Alkem Laboratories, Amgen, Bayer, Boehringer Ingelheim, Colgate Palmolive, Hetero Drugs, Ipca Laboratories, Macleods Pharma, Merck and Co, Mylan, Novo Nordisk, Pfizer, and Wockhardt, we are delighted to be hosting our second event. The agenda will continue to build on the theme of PV Inspection Readiness and will include:
- The latest PV Regulatory Context – spotlight on the evolving landscape in India
- The global PV system – balancing global and local requirements
- The pvindia community moving forward
pvindia will provide a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
For further information please click here
To register your interest in participating, please click here. If you have any further questions then please contact a member of our pvindia team at pvindia@navitaslifesciences.com
Nordic Pharmacovigilance Day 2016
Venue: Park Inn by Radisson, Copenhagen Airport Hotel, Copenhagen, Denmark
Navitas’ Head of pvtech and Senior Consultant, Martin Holm-Petersen, is a member of the Scientific Board and will be co-chairing this event.
Navitas’ Managing Consultant, Tido Eger, will be presenting on ‘Integrating medical devices into pharma PV and RA departments’.
For further information please visit the event website at: http://nordicpharmacovigilanceday2016.eventify.it/
Sidley ctlegal Biannual Meeting
Venue: Helsinn, Lugano, Switzerland
This event will see life sciences peers engaging in topical conversation, learning and networking. This interactive meeting will include hot topics in clinical trials (EU and USA), benchmarking trends, and practical case studies, and industry issues.
Navitas’ Senior Consultant, Janet Fernihough, will be presenting at this meeting on the topic of; ‘Risk Based Monitoring, Personalised Medicine, and Patient Engagement’
Hosted by Sidley Austin LLP, ctlegal is a membership based network for in-house counsel and compliance personnel at pharmaceutical companies working on clinical trial issues in the Life Sciences sector. The network includes regular forums supported by the benchmarking of member performance and best practice sharing in the area of clinical trials.
For further information please visit the network website at: http://ctlegal.navitas.net/ or contact ctlegal@sidley.com
Navitas Networks IDMP – Getting Ready webinar
Time: 15:30 – 17:00 British Summer Time
Hosted by Navitas Networks this webinar will be presented by Navitas’ Senior Consultant Gary Aldam.
The webinar will address the following:
- The evolving IDMP regulatory landscape
- How does industry prepare?
- A working group perspective
- A range of approaches
- Getting Ready for IDMP
- Roadmap for success, with real industry examples
- Success strategies and lessons learnt
- Looking forward
- Ready or not, how success will be measured
- Close and next steps
To register please click here
For further information please contact networks@navitaslifesciences.com
DIA 10th European Forum for Qualified Person for Pharmacovigilance (QPPV)
Venue: The Crystal, London, UK
Now in its tenth year, the DIA European Forum for QPPV will look to meet the following objectives:
- Hear the latest updates and hot topics relating to the role of the QPPV
- Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of QPPV
- Network with colleagues and meet regulators
- Learn from and share experience and ideas with like-minded QPPVs in a neutral environment
- Take away practical hints and tips
- Better understand regulatory and inspectorate expectations of the QPPV
- Identify the expanded expectations of the role in the context of the new regulatory framework and transparency initiatives
- Examine current areas of real challenge
Navitas’ Principal Consultant, Jeff Ho, will be presenting a poster presentation at this meeting titled ‘Efficient Content Management for the compilation and management of the PSMF’. This poster will evaluate the potential opportunities for efficient management of content utilised in the compilation and management of the PV System Master File.
To view the event programme, please click here
To arrange to meet with Jeff Ho, please contact us at info.europe@navitaslifesciences.com
Navitas Networks and AbbVie webinar PV Organisations Reimagined - Roadmap to transforming into a strategic PV organisation
Time: 15:30 – 17:00 British Summer Time
Hosted by Navitas Networks and AbbVie, this webinar will be presented by Navitas’ Principal Consultant, Wilfred Gilich and, from AbbVie, Dr. Linda Scarazzini, Vice President PV and Patient Safety, Jenifer Koeller, Senior Director Business Solutions PV and Patient Safety, and Kemi Yusuf, Director Business Solutions Project Management PV and Patient Safety. The webinar will address the following:
- The rapidly changing landscape for PV organisations
- How PV organisations must respond
- Anatomy of a strategic PV organisation
- A case study from AbbVie
- Roadmap to defining the PPS (Pharmacovigilance and Patient Safety) 2020 vision
- Bringing PPS 2020 to life
- Impact and results…so far
- What lies ahead?
- Key learnings for other PV organisations
- Looking forward
To register please click here
For further information please contact networks@navitaslifesciences.com
Sparta Systems and Navitas Webinar: Addressing IDMP System Requirements with TrackWise
Time: 11:00 ET
This webinar will provide an overview of the FDA Guidance for the recent IDMP regulation and explain how pharmaceutical companies should prepare and build a solution to meet the IDMP specifications that are connected to the TrackWise system.
- Scott Mitreuter, Product Management at Sparta Systems
- David Gwyn, Head of Technology at Navitas, Inc.
- FDA and ISO requirements for IDMP
- Establishment of an IDMP strategy
- Develop a solution to meet the new IDMP guidelines
- Integration between Sparta Systems’ TrackWise and Navitas
This webinar will provide insight for pharmaceutical companies on building a strong solution to meet the regulatory requirements of IDMP. To register your attendance please visit the event website here.
RAPS 2016 Regulatory Convergence
Venue: San Jose, California
Navitas will be highlighting regulatory solutions at the Regulatory Affairs Professionals Society annual meeting. IDMP is a popular topic with regulatory professionals and Navitas will showcase IDMP best practices along with idmpREADY Navitas will also provide attendees with case studies and demos of pharmaREADY, the end – to – end regulatory software suite, which is comprised of eCTD, Document Management, Structured Product Label Management, Training Records Management and Paper Submissions modules.
Navitas will also talk about regulatory submissions and publishing services. Navitas provides submission and publishing services for leading life science companies throughout the world and has regulatory operations hubs in India and Colombia.
If you would like further information, please contact us at: contact@navitaslifesciences.com
DIA Global Labeling 2016
Venue: Omni Shoreham Hotel, Washington DC, USA
The DIA Global Labeling 2016 conference has been developed in collaboration with the Regulatory Affairs Community Labeling Working Group and will address the following topics:
- Global Labeling issues and updates
- Labeling role
- Pharmacovigilance Risk Assessment
- Packaging issues
- Combination products
- Biosimilars
- Patient leaflet
- Plain language labeling
- Patient Medication Information (PMI)
- International Strategic Plan
For further information please visit the DIA event website here or to arrange to meet with Tara please contact us at contact@navitaslifesciences.com
Navitas’ pvindia Webcast: Getting Inspection Ready
Venue: 14:00 – 15:30 IST
Hosted by Navitas’ pvindia Network, and presented by Louise Jebson, Head of Networks at Navitas Life Sciences and Jean-Christophe Delumeau, Head of Pharmacovigilance China and Asia Pacific at Bayer HealthCare, this webcast will explore the topic of ‘Getting Inspection Ready’. Staying abreast of what regulatory authorities require can be difficult to achieve. Success or failure of an inspection from a regulatory authority is determined by both practice and preparation. This webinar highlights the obstacles and pitfalls, strategy design, together with making inspection management a priority.
- Latest Regulatory Context
- Global trends and context
- Emerging Indian regulations
- A case study approach to Audits and Inspections - Bayer HealthCare
- 5 Steps to Inspection Readiness
- An integrated approach and mindset
- PSMF – core and local
- Governance and roles
- Compliance metrics and KPIs
- Managing CAPAs
- Where next?
This webcast is hosted by Navitas’ pvindia Network; to find out more about pvindia please click here.
CPhI’s Unannounced Audits Workshop
Venue: The Westin Mumbai Garden City, Mumbai
Navitas along with Sparta Systems is exhibiting at CPhI’s Unannounced Audits Workshop, which guarantees routine success in FDA inspections which would integrate company culture built on sustaining compliance, significant training and preparation, and flawless execution during the inspections. One can learn from leading USFDA pharma experts on managing audits in complex environments. Mohan Ponnudurai of Sparta Systems will be presenting on audit capabilities of TrackWise including risk assessments and compliance.
Visit our stand to know more about Navitas’ proprietary implementation framework – qualityREADY, designed to deploy TrackWise EQMS Application for your organization. This framework accelerates TrackWise implementations, reduces risks and lowers costs, brings industry best practices to business processes and provides flexibility to allow key configurations while ensuring audit readiness.
If you would like further information, please contact us at: contact@navitaslifesciences.com
Next Generation PV Tools’ webcast
Time: 15:30 – 17:00 British Summer Time
Hosted by Navitas Networks, this webcast will be presented by Navitas’ Senior Consultant, Martin Holm-Petersen. The webcast will address the following:
- IT as the game changer
- Exploring macro-trends that are changing the technological landscape for Pharma
- Technology drivers that are changing how we do PV
- What does digitally transformed PV look like?
- Automation, new sources of data, machine learning, and unstructured text analysis, generation of insights
- Building IT strategies for PV
- Drivers and challenges
- Cross portfolio strategies
- Roadmap for success
To register please click here
For further information please contact networks@navitaslifesciences.com
DIA 2016 52nd Annual Meeting
Venue: Pennsylvania Convention Center, Philadelphia, USA
Navitas is delighted to have three of our Expert Navigators presenting at the DIA’s 52nd Annual Meeting.
Tuesday 28 June, 2016 10:30 – 11:45
Navitas’ Managing Consultant, Hershell Thompson, will be chairing the session ‘The Global Conundrum: Herding Cats – Identifying Risk across Pharmacovigilance networks and seeking simplicity in multi-country Pharmacovigilance activities’
For further information please click here
Tuesday 28 June, 2016 16:00 – 17:15
Navitas’ Principal Consultant, Denis Fung, will be speaking as part of the ‘Improving Adverse Drug Reaction Information in Product Labels’ session
For further information please click here
Navitas will also be presenting a poster titled “End – to – End Change Control: An Integral Approach to Product Changes, Submissions and Variation Management”, which explains the basic concepts of End – to – End change control and provides key insights into the key benefits and challenges relating to End – to – End change control.
If you would like to arrange to meet with a member of our team at the DIA event then please do get in touch at contact@navitaslifesciences.com
pvconnect Forum
Venue: London
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
For further information or to register your interest in participating at this meeting, please contact us at pvconnect@navitaslifesciences.com
pvtech Forum
Venue: London
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
For further information or to register your interest in participating at this meeting, please contact us at pvtech@navitaslifesciences.com
pvnet Summit
Venue: London
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
For further information or to register your interest in participating at this meeting, please contact us at pvnet@navitaslifesciences.com
pvconnect Forum
Venue: New York
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
For further information or to register your interest in participating at this meeting, please contact us at pvconnect@navitaslifesciences.com
labelnet Forum
Venue: New York
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
If you are interested in further information or to register your interest in participating, please contact us at labelnet@navitaslifesciences.com
pvtech Forum
Venue: New York
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
If you are interested in further information or participating at this meeting, please contact us at pvtech@navitaslifesciences.com
rimnet Forum
Venue: New York
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held in October, 2014 and May and June, 2015, again in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact us at rimnet@navitaslifesciences.com
pvnet Summit
Venue: New York
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvnet@navitaslifesciences.com
Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
5th last webinar of this series - Application Management Services
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)
Navitas’ Application Management Services (AMS) allow you to get the most out of your IT investments by reducing your cost of management and support, whilst increasing customer satisfaction and quality of service. This webinar will talk you through the Navitas application lifecycle approach.
Register Now!
7th Outsourcing in Clinical Trials East Coast 2016
Venue: King of Prussia, Pennsylvania
Georgina Wood, Navitas’ Clinical Data Solutions Practice Lead, will speak at the 7th Annual Outsourcing in Clinical Trials East Coast conference May 25th & 26th in King of Prussia, Pennsylvania. According to research, the clinical outsourcing market will increase from $38 Billion to $64 Billion by 2020. The vendor selection process is time consuming, costly and often based on subjective criteria rather than on objective analysis. Ms. Wood will outline how companies can utilize industry best practices to improve their vendor selection process as well as improving their bottom line.
Navitas Highlights Quality and IDMP at Sparta Connection Orlando
Venue: JW Marriott Grande Lakes, Orlando, Florida
Navitas is a platinum sponsor at the Sparta Connection conference in Orlando, Florida May 23-26. Sparta Connection attendees will gain insights into how game-changing technology and strategies in mobile, SaaS and business analytics are propelling companies to new heights. Navitas will be highlighting qualityREADY®, which accelerates TrackWise implementations, reduces risks and lowers costs, brings industry best practices to business processes and provides flexibility to allow key configurations while ensuring audit readiness. Also highlighted will be idmpREADY®. idmpREADY is Navitas’ technology solution that enables life science companies to comply with coming regulations in Europe and throughout the world.
rimnet Forum
Venue: Sidley Austin LLP offices in London
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York and London with participation from 13 companies. The positive feedback from the participants, and the need for further discussion led to events being held in October, 2014 and May and June, 2015, again in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact us at rimnet@navitaslifesciences.com
labelnet Forum
Venue: Sidley Austin LLP offices in London
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
If you are interested in further information or to register your interest in participating, please contact us at labelnet@navitaslifesciences.com
Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
4th webinar of this series - Increase your upgrades to reduce your cost and complexity
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)
Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. In this webinar we will talk you through Navitas’ forward thinking approach to system upgrades.
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Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
3rd webinar of this series - Data Migration
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)
Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. Migrating legacy safety applications can be a daunting task due to the complexities involved. Navitas has prebuilt migration packages that enable rapid, compliant migrations from legacy applications (as well as Excel spreadsheets) to help smooth your implementation and provide peace of mind.
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2016 Blue User Conference
Venue: Chicago Athletic Association Hotel, Chicago, IL
Tara Baer from Navitas speaks at the 2016 Blue User Conference. Tara Baer, labeling expert from Navitas, will present “Breaking Down the Walls for a Better Process” on April 26th at 8:45 a.m.
Tara is an experienced leader in Medical Device and Pharmaceutical labeling. She has worked at such industry leaders as AbbVie, Boston Scientific, Wyeth and Intervet, where she developed a passion for End-to-End Labeling Management, from safety through distribution. An experienced manager, guide and motivator, she has led diverse teams of professionals towards collaborative solutions. Tara has a proven record of accomplishment of successfully delivering projects with aggressive timelines and budgets, with a focus on risk and quality management. She specializes in translation management, workflow, content development, automated tracking/process integration, and asset management.
CPhI’s CAPA & Root Cause Investigation Workshop
Venue: Meluha The Fern, Mumbai, India
Navitas along with Sparta Systems is exhibiting at CPhI’s CAPA & Root Cause Investigation Workshop, which is the only forum in India dedicated to identifying non-compliance, understanding the root cause, and responding with appropriate corrective and preventive actions for the Pharmaceutical companies. Mohan Ponnudurai of Sparta Systems is a speaker at this event.
Visit our stand to know more about Navitas’ proprietary implementation framework – qualityREADY, designed to deploy TrackWise EQMS Application for your organization. This framework ensures high quality regulatory compliant deployment within a short timeframe. This framework comprises of accelerators for Process Design, Configuration, Validation, Data Migration and Training.
If you would like further information, please contact us at: contact@navitaslifesciences.com
Navitas - Oracle Webinar Series: Oracle Argus Implementations migrations, upgrades & maintenance
2nd webinar of this series - Accelerated Oracle Argus Implementations
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)
Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you. This webinar will explain how our accelerators can fast track your Oracle Argus implementation whilst ensuring it is tailored to your specific business requirements.
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India - TrackWise User Group (TUG)
Venue: Hyatt Regency, Mumbai
Navitas and Sparta Systems will host the 2nd TrackWise User Group (TUG) meeting on 20th April 2016 at the Hyatt Regency, Mumbai. The event is a platform for TrackWise users across India to connect and share their experiences and best practices. Users can also learn from experts on how to get more from their investments in TrackWise.
If you would like further information, or you would like to register to attend this meeting, please contact us at: contact@navitaslifesciences.com
Labelling End-to-End Tracking Tools in Action Webcast
Time: 15:30 – 17:00 BST
Hosted by Navitas Networks, this webcast will be presented by David Gwyn, Head Technology Practice at Navitas Life Sciences, Inc. and Craig Trautman, CEO, Intagras. The webcast will address the following:
- A reminder of why E2E tracking is key
- The start and end point of labelling
- Tracking tools in action
- Looking forward
To register please click here
For further information please contact networks@navitaslifesciences.com
The Digital Transformation in Pharma
Venue: Tivoli Hotel and Congress Center, Copenhagen, Denmark
Navitas’ Senior Consultant, Martin Holm-Petersen, will be presenting a session titled ‘Realigning pharma – patient data driven scenarios’ on Wednesday 13 April from 11:00 – 11:45. This session will explore how pharma companies are looking for future opportunities emerging from new data sources. It will explore scenarios as well as a case study for bringing patient/consumers closer to the business via mHealth and personal health records. The session will also discuss:
- How real-world evidence will integrate in the pharma value chain
- How it will impact the pharma business operating model and cause internal realignment within organisations
Navitas - Oracle Webinar series: Oracle Argus Implementations, migrations, upgrades and maintenance
Time: 15:00 (BST), 16:00 (CEST), 10:00 (EDT)
Navitas in partnership with Oracle is pleased to invite you to a series of Oracle Argus webinars. Whether you are considering an Oracle Argus implementation, looking to upgrade your existing system or want to consider your options for system maintenance, these webinars are for you.
First of the series is Oracle Argus in the Cloud. This webinar will talk you through the advantages of cloud implementations, our expedited approach to implementation and the options open to you.
Register Now!
IDMP - From Concept to Reality Webcast
Time: 15:30 – 17:00 BST
Hosted by Navitas Networks, this webcast will be presented by Rens van den Boomen, Managing Consultant at Navitas Life Sciences and will address the following:
- Latest Regulatory context for IDMP
- IDMP – 5 steps to success
- Maturity Assessment
- Strategy Roadmap
- Program Management
- System Implementation
- IDMP Deployment
- Where next?
For further information please contact networks@navitaslifesciences.com
5th Annual Clinical Data Integration and Management 2016
Venue: Princeton, New Jersey
Georgina Wood, Clinical Data Practice Leader for Navitas, will present “Clinical Data Integration – Integral to Risk Based Monitoring, Quality based payments and SDTM like outputs” at the 5th Annual Clinical Data Integration & Management conference Tuesday, March 22nd in Princeton, New Jersey.
Her session will discuss how to establish next generation clinical analytics by incorporating a robust clinical data integration platform as an essential and pre-requisite foundational architectural component. Realizing differences in scope and complexity of integration across enterprises by adopting SaaS based data collection and clinical trials management systems will be explored. Also covered will be:
- Analyzing a custom development of a data warehouse with scope of integrating data from output for operational and bio-statistical programing needs
- Discussing a SaaS based integration platform with the scope of integration across all systems enabling adaptive monitoring (RBM with Central and Medical Monitoring)
This session will take place at 11:30 on Tuesday, March 22nd.
Pharmacovigilance 2016
Venue: DGI-byen Conference Centre, Copenhagen, Denmark
Navitas’ Senior Consultant, Martin Holm-Petersen, will be part of an expert panel discussion on PASS and PAES designs at this event. The session will explore:
- Secondary use of health data
- Use of big data sources in PV – how far are we?
- Data driven pharmacovigilance and elaborate post authorisation monitoring of benefit-risk in the market has been conceptualised, but how far are we in the industry?
- Industry perspectives – a hot topic
For further information please visit the event website at: http://insightevents.dk/events/pharmacovigilance-2016/
Venue: JW Marriott San Antonio Hill Country, San Antonio, Texas
Navitas will be highlighting its traceREADY Warehouse Edge System at the HDMA Conference. HDMA is the national association representing primary healthcare distributors, the link between the nation’s pharmaceutical manufacturers and healthcare providers.
Navitas’ traceREADY Warehouse Edge System enables the capture of serialized warehouse transactions which regulations mandate the recording of all business events in a centralized repository for enabling Track and Trace for supply chain security.
In order to ensure accurate and timely data from the packaging line, it is necessary to have an application to collect the required data and transfer the same to the central repository.
traceREADY automates warehouse / manufacturing transactions, meets validation requirements and complies with GxP norms, supports multiple form factors on Windows, Android and iOS devices and enables online and offline mobile transactions. traceREADY was designed to be a highly configurable and scalable architecture and integrates seamlessly with ERP (SAP, Oracle, JDE) and EPCIS repositories.
To learn more or to view a demo, visit Navitas in booth 112 at the HDMA conference.
pvindia Forum
Venue: Mumbai, India
Navitas is delighted to announce that we will soon be adding to our portfolio of industry leading networks with the launch of pvindia; a network for Heads of Safety of Indian life sciences companies with pharma, consumer, generics, or mixed portfolios.
pvindia will leverage the approach, format and experience gained from successfully running pvnetworks over the past 14 years in Europe and the USA. This is a unique opportunity to be part of the industry leading global network for pharmacovigilance professionals.
pvindia will provide a neutral platform for pharmacovigilance leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues.
For further information please click here to register your interest in participating, please contact a member of our networks team at pvindia@navitaslifesciences.com
Pharma Packaging and Labeling USA 2016
Venue: Philadelphia, USA
Navitas Speaking at the Pharma Packaging and Labeling USA 2016.
Navitas will present innovative packaging and labelling strategies and tactics at the Pharma Packaging and Labeling USA 2016 conference. David Gwyn, Navitas’ technology practice leader, will discuss models for success for effective labelling that aligns across functions to deliver a compliant, label management process.
Global PV Connections - Managing across borders Webcast
Venue: 15:30 – 17:00 GMT
Hosted by Navitas Networks, this webcast will be presented in three sections and will address the following:
Presented by Jeffrey Ho, Principal, Navitas Life Sciences
- Building global connections
- Managing across borders - affiliates and partners
- Assessing risk and resource needs
- Strategies for success
Speaker to be confirmed
- The shifting global PV context
- Shifting regulations and a complex landscape
- Rising volumes and headcount squeeze
Presented by Lesia Tontisakis, Director of PV, Allergan
- Case Study: Developing an improvement plan; preventing pitfalls and realising benefits
For further information please contact networks@navitaslifesciences.com.
ECCRT Seminar: Outsourcing models in Clinical R&D
Venue: Pullman Hotel - Place Victor Horta 1 - 1060 Brussels
Navitas’ Shalabh Kumar to speak at the European Centre for Clinical Research Training
Shalabh Kumar, Navitas’ Global Head of Outsourcing Services, will speak at the February 4th European Centre for Clinical Research Training seminar at the Pullman Hotel in Brussels. Mr. Kumar, along with Eric Chleide and David Baugnies of GSK Vaccines, will explore the benefits and possible pitfalls of Clinical R’D outsourcing models.
Safety Requirements for Medical Devices and Combination Products
Venue: 15:30 – 17:00 GMT
Hosted by Navitas Networks, this webcast will be presented in three sections and will address the following:
Presented by Tido Eger, Navitas
- Safety drivers for pharmaceutical companies in the medical device space
- The differences between drug and device requirements, including drug vs. device reporting
- The challenges for pharmaceutical companies around Safety reporting for devices and CP
- The view and solutions from Navitas
- Current safety requirements – focus on vigilance reporting
- Enforcement landscape and expectations of authorities and notified bodies
- Medical Devices and IVD Regulations – thoughts on new safety requirements
- Case study: what we are seeing in industry, our approach, solution, and challenges
To register please click here
For further information please contact networks@navitaslifesciences.com
rimnet Forum
Venue: Sidley Austin LLP offices in London
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact us at rimnet@navitaslifesciences.com
IDMP Readiness Revisited Webcast
Venue: 15:30 – 17:00 (GMT)
Owing to the popularity of this webcast back in October, we will be re-running the session.
Hosted by Navitas Networks, this webcast will explore IDMP Readiness and address the following:
- Latest update on regulatory context for IDMP
- Real-time IDMP examples – the challenges our clients are facing
- IDMP readiness – what good looks like
- Where next?
rimnet Forum
Venue: Sidley Austin LLP offices in New York
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.
MMoving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact us at rimnet@navitaslifesciences.com
pvtech Forum
Venue: Sidley Austin LLP offices in New York
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
If you are interested in further information or participating at this meeting, please contact us at pvtech@navitaslifesciences.com
pvconnect Forum
Venue: Sidley Austin LLP offices in New York
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvconnect@navitaslifesciences.com
pvnet Summit
Venue: Sidley Austin LLP offices in New York
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvnet@navitaslifesciences.com
Venue: 11 AM EST
Legal Contract Management – control your contracts by leveraging the power of metadata. Review a dashboard of upcoming contract renewals, determine the value of what is ahead combined with the workload and the resources needed. Witness what is possible through a next-generation user experience in an environment where simple solutions are often the most useful. Take control of your contracts instead of them controlling you.
Register Now!
pvconnect Forum
Venue: Sidley Austin LLP offices in London
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvconnect@navitaslifesciences.com
pvtech Forum
Venue: Sidley Austin LLP offices in London
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
If you are interested in further information or participating at this meeting, please contact us at pvtech@navitaslifesciences.com
Venue: 11 AM EST
Human Resource Management – integrate the management of offer letters, personnel files and other critical HR documents in the same platform you use for the rest of your business. Provide automated review and approval processes both in the office and through mobile devices and avoid manual paper processing. Take your HR environment to the next generation while leveraging your current content management investment.
Register Now!
pvnet Summit
Venue: Sidley Austin LLP offices in London
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvnet@navitaslifesciences.com
Venue: The Westin, Mumbai, India
Navitas is participating along with Sparta Systems in this workshop that brings you a two-day Data Integrity, Reliability & Quality Metrics. The workshop focuses on the issues related data integrity, reliability and also on quality metrics and pilot programs in the US. Experts from Lachman Consultants will be conducting the Workshop.
Venue: 11 AM EST
Quality – manage you standard operating procedures (SOP), work instructions, specifications, analytical methods and other quality-related documents in a sip le yet powerful user interface. Manage the lifecycle of the documents from draft through effective and control where documents are printed and who can access copies and at what status. Witness the simple power of scanning a QR code to retrieve the current SOP on the shop floor with your handheld device. Experience simple, innovative and controlled quality document management.
Register Now!
Venue: Baltimore, Maryland
Navitas will be highlighting regulatory operations outsourcing solutions, along with eCTD software, at the Regulatory Affairs Professional Society (RAPS) annual meeting.
The solutions highlighted will include Submissions & Report Publishing, License Maintenance, Labeling & Artwork Services, Regulatory Information Management and Regulatory Strategy & Support. Additionally, pharmaReady®, Navitas’ suite of fully integrated regulatory document management system, from document creation through regulatory submissions, will be demonstrated.
Venue: 11 AM EST
Correspondence Management – track communications more effectively by collating all information together in a single entity in your repository. Witness the integration of emails with attachments from a regulatory authority being stored as combined PDF document, complete with a forms-based manifestation of all critical metadata about the correspondence. Reduce your stress level when tracking and responding to health authorities with the next-generation user experience.
Register Now!
Venue: 11 AM EST
Mobile Access – experience content management 21st century where key decision makers can review and approve documents securely from their mobile devices. Watch a live demonstration showing interaction between a user on their computers and a user on their mobile phone. See how efficient it can be to work remotely using a custom-built application instead of a mobile browser, logging in with a scan of a thumbprint and signing a document without putting a pen to paper.
Register Now!
Venue: 15:30 – 17:00 (British Summer Time)
Hosted by Navitas Networks, this webcast will explore IDMP Readiness and address the following:
- Latest update on regulatory context for IDMP
- Real-time IDMP examples – the challenges our clients are facing
- IDMP readiness – what good looks like
- Where next?
Most Marketing Authorisation Holders, as well as Contract Manufacturing Organisations, are starting to prepare for IDMP. A global compliance requirement that will become legally enforceable by the EMA from the middle of 2016 onwards.
During the summer period, the EMA IDMP Taskforce has given an insight to the approach they are proposing to the European Commission to follow. Although timelines are more realistic, the amount of effort involved, associated budgets required, and resources to plan for over the years to come, are still very substantial.
There is no doubt, from an objective perspective, that what IDMP proposes makes good sense. However, what we have seen so far within our client engagements, is that the transition to IDMP raises a lot of challenges, both technological as well as organisational.
There are many elements to IDMP that organisations need to consider, compliance to the EMA, although important, is just one of them. In order for global organisations to ensure that a truly long-term sustainable solution is in place they must think of IDMP holistically.
Click here to view our latest thoughts on IDMP.
Venue: 11 AM EST
Electronic Trial Master File (eTMF) – learn how to manage your TMF electronically, reducing your dependence on paper files while maintaining a compliant repository. See how you can scale this platform by selectively opening access to external partners and providing a user experience that Principal Investigators and Clinical Research Assistants can use without training. Experience an integrated solution that connects with your regulatory submission platform to enable sharing of documents and eliminating duplicates and mistakes.
Register Now!
Venue: Renaissance Arlington Capital View Hotel, Arlington, Va.
Navitas is proud sponsor at this prestigious conference that provides details on the key requirements for implementation of the DSCSA, with a legislative and regulatory review and insights into state requirements and pre-emption.
Venue: Hotel Sofitel, Bandra East, Mumbai, India
The 18th Indian Drug Manufacturers APA Pharmaceutical Analysts’ Convention is themed around ‘Quality and Compliance – Global Expectations’. The convention will look at global requirements in the field of Quality Management and Regulatory Compliance and address the issues and challenges facing the industry.
On Friday 09 October, Navitas CEO, Jim Tizzard will address delegates with a session titled ‘Quality and Compliance, Reputation and Leadership’. In addition, Navitas’ Head of Operations, Marty Boom, will present a session titled ‘‘Integrating to the global QMS – best practices’
For further information about the event, please visit the IDMA website here
Venue: Country Inn & Suites By Carlson, Mysore, Karnataka India
Navitas is proud sponsor at this prestigious conference that encourages statistical programmers from the healthcare industry to convene, and provides a platform to share novel ideas in statistical programming, network and strengthen statistical programming community in India.
Venue: Copenhagen Park Inn by Radisson, Copenhagen Airport Hotel, Denmark
Navitas’ Principal Consultant, Jeffrey Ho, and Senior Consultant, Martin Holm-Petersen, will both be speaking at the Nordic Pharmacovigilance Day 2015.
Martin Holm-Petersen is a member of the Scientific Board and will co-chair the event with Anne Gramkow, Head of Drug Safety and QPPV at Pharmacosmos. The event will share best practices, results, and experiences within the field of Pharmacovigilance.
Navitas’ Jeffrey Ho will present a session on Affiliate PV Risk.
Further information can be found on the event website here.
TAKE Academy of Life Sciences and Leadership One day Workshop: Regulatory Compliance with Current Challenges
Venue: 09:00 – 17:30, Taj Krishna, Hyderabad, India
Navitas’ Principal Consultant, Oliver Steck will be speaking at this one day workshop focusing on Regulatory Compliance with Current Challenges
The workshop will address:
- Challenges relating to PDUFA fees
- Process development
- Technology transfer
- Exhibit batches
- Data generation
- Stability data
This workshop will provide valuable insights through case studies and methodologies, to all sterile and non-sterile pharma and biotechnology industries. The program is aimed at:
- CEOs
- Directors
- VPs
- GMs
- Senior Managers
Further information and details of how to register can be found on the event website here
TAKE Academy of Life Sciences and Leadership One day Workshop: Regulatory Compliance with Current Challenges
Venue: 09:00 – 17:30, Taj West End, Bangalore, India
Navitas’ Principal Consultant, Oliver Steck will be speaking at this one day workshop focusing on Regulatory Compliance with Current Challenges
The workshop will address:
- Challenges relating to PDUFA fees
- Process development
- Technology transfer
- Exhibit batches
- Data generation
- Stability data
This workshop will provide valuable insights through case studies and methodologies, to all sterile and non-sterile pharma and biotechnology industries. The program is aimed at:
- CEOs
- Directors
- VPs
- GMs
- Senior Managers
Further information and details of how to register can be found on the event website here
Webinar: EDM Submission Reference Model - Shaping how submission content is managed
Venue: 10:00–11:00 Eastern Time
Navitas’ content management practice lead, David Gwyn, will be speaking on the EDM Reference Model. IRISS is recognized as a pharmaceutical industry trade organization, which provides a mechanism for IRISS (Implementation of Regulatory Submission Standards) to collaborate with other trade organizations within the pharmaceutical industry (i.e. PhRMA, DIA, RAPS, HL7) as well as global health authorities.
Mr. Gwyn’s presentation “EDM Submission Reference Model - Shaping how Submission Content is Managed” will showcase the output of DIA’s (Drug Information Association) EDM Submission Reference Model team and present the background of how the model was created, where it is today and the future roadmap of development. The session will conclude with information on how to obtain the model and how to participate in future activities. The topic and content are the output of DIA’s (Drug Information Association) EDM Submission Reference Model team that Mr. Gwyn led.
Register Now!
5th Annual Medical Device Global Regulatory Intelligence Conference
Venue: Alexandria, Virginia
Mayank Raizada will be presenting ‘Regulatory Aspects and Practical Considerations for Combination Product Surveillance’. Mayank’s session will explore the impact of regulations for managing Combination Products on safety surveillance and product quality while providing an understanding on how the variability in combination product regulations is forcing companies to re-evaluate the functioning to ensure compliance and maintain efficiency.
The talk will also provide attendees the building blocks for setting up a compliant and efficient process for managing combination product surveillance, highlighting how governance can be the glue that binds Process, Organization, and Compliance together where functional ownership fails.
End-to-End Labelling webinar
Date: 01 July, 2015
| Time: | 16:30 – 18:00 Central European Time 15:30 – 17:00 British Summer Time 10:30 – 12:00 Eastern Daylight Time |
Label management is a complex activity that is on-going throughout the lifecycle of a pharmaceutical product. Effective labelling, from label creation and updates through to implementation, is a truly cross-functional process which spans across Pharmacovigilance, Regulatory Affairs, Medical Affairs, and Supply Chain. The need to have E2E labelling oversight is now a regulatory expectation and no longer just a future requirements. E2E tracking of status and timelines is an essential part of enabling E2E labelling oversight, i.e. from confirmation of safety signal to label implementation ‘in pack’.
Presented by Denis Fung, Senior Managing Consultant at Navitas, this webinar will look to address the following:
- End-to-end labelling – why is it important?
- Patient Safety
- PV Compliance
- A new paradigm of E2E labelling – from signal to patient
- What does good look like? Process, Governance, and Technology
- One goal, one voice: the cross-functional paradigm (PV, RA, Supply Chain, Medical Affairs, etc.)
- Looking forward
If you would like further information, or you would like to register to attend this webinar, please contact us at: info.europe@navitaslifesciences.com
Sparta Connection 2015
Venue: Swan and Dolphin Resort in Orlando, FL, USA
Navitas is the Gold Sponsor of Sparta Connection. Navitas’ Dave Gwyn will talk about the critical issues Life Science companies face with their TrackWise implementation, upgrades, data migration, reporting, integrations, support and the advantages of cloud hosting.
Also presenting at the conference are representatives from Roche, Johnson & Johnson, GE Healthcare, Otsuka, Janssen, Stryker, BD, Eli Lilly, Perrigo, Genentech and more.
pvnet Summit
Venue: Sidley Austin LLP offices in London
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvnet@navitaslifesciences.com
pvconnect Forum
Venue: Sidley Austin LLP offices in London
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvconnect@navitaslifesciences.com
pvtech Forum
Venue: Sidley Austin LLP offices in London
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
If you are interested in further information or participating at this meeting, please contact us at pvtech@navitaslifesciences.com
labelnet Forum
Venue: Sidley Austin LLP offices in New York
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
If you are interested in further information or participating at this meeting, please contact us at labelnet@navitaslifesciences.com
pvtech Forum
Venue: Sidley Austin LLP offices in New York
pvtech is the joint pvnet and pvconnect interest group for individuals responsible for enabling and supporting PV technologies in their organisations.
Our vision is to shape the future of technology in Pharmacovigilance by providing business and technology leaders with an open environment to share challenges, but also discuss alternative solutions and develop best practices that are aligned to the future of Pharmacovigilance whilst increasing business value from their technology investments.
If you are interested in further information or participating at this meeting, please contact us at pvtech@navitaslifesciences.com
pvconnect Forum
Venue: Sidley Austin LLP offices in New York
Established in 2006, pvconnect provides a neutral platform for PV leaders facing similar challenges to network, debate, compare performance and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvconnect@navitaslifesciences.com
rimnet Forum
Venue: Sidley Austin LLP offices in New York
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2015, again in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact us at rimnet@navitaslifesciences.com
pvnet Summit
Venue: Sidley Austin LLP offices in New York
Established in 2001, pvnet provides a neutral platform for Pharmacovigilance (PV) leaders facing similar challenges to network, debate, compare performance, and share ideas on how to tackle the latest hot issues – balancing rising workload with resource constraints, managing divergent global regulatory requirements, implementing continuous benefit risk management, leveraging big data, and modernising PV in the context of the seismic technology and industry shifts.
If you are interested in further information or participating at this meeting, please contact us at pvnet@navitaslifesciences.com
rimnet Forum
Venue: Sidley Austin LLP offices in London
Discussions around Regulatory Information Management (RIM) within our drug safety and labelling oriented forums, pvnet, pvconnect, and labelnet, led to the initiation of a roundtable to provide a platform to share and discuss the emerging area of RIM.
Established in 2014, the first roundtable was held in May, 2014 in New York City and London. The positive feedback from the participants, and the need for further discussion led to a second roundtable being held in fall 2014, again in both locations.
Moving forward, our vision for rimnet is to provide regulatory professionals with a network to be able to share and openly discuss challenges, approaches, and best practices in respect of RIM.
If you are interested in further information or participating at this meeting, please contact us at rimnet@navitaslifesciences.com
labelnet Forum
Venue: Sidley Austin LLP offices in London
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
If you are interested in further information or participating at this meeting, please contact us at labelnet@navitaslifesciences.com
Pharma SUG Annual Conference
Venue: Ornaldo, FL, US
Navitas will present “Accelerate define.xml generation using Define Ready” at the Pharma SUG Annual Conference in Orlando, May 18th at 9:30a.m. in the Oceans Ballroom 3 at the Renaissance Orlando at Seaworld. The presentation looks at the FDA & other regulatory agencies mandate of electronic submissions and standardized data, along with CDISC SDTM and ADaM based standards. An important component of such submissions is the generation of the CRT-Data Definition Document (Define xml).
Benefit:Risk Management (BRM) webinar
Date: 12 May, 2015
| Time: | 16:30 – 18:00 Central European Time 15:30 – 17:00 British Summer Time 10:30 – 12:00 Eastern Daylight Time |
Navitas are excited to announce the second webinar of our series, focusing on the topic of Benefit:Risk Management (BRM).
Health Authorities around the world require that Life Sciences companies perform comprehensive evaluations of their products’ Benefit:Risk relationships throughout their lifecycles, based on information sourced from numerous stakeholders who have not traditionally been intimately engaged in pharmacovigilance activities. In response, companies are establishing and refining processes, tools, and governance structures to ensure that all relevant efficacy and safety information is considered, and that related decisions are implemented and effective. Increasingly sophisticated methods to gather and analyse safety and benefit information are being employed, responding to the challenges associated with doing so, addressing the implications of the results, and monitoring the effectiveness of their responses to these analyses.
The environment continues to evolve, however, as both patients and payers follow and analyse Benefit:Risk information more closely and, in fact, base selection and reimbursement decisions on this information. As a result, companies must respond to current requirements regarding Benefit:Risk analysis while closely monitoring and responding to the expectations of regulators, payers, and patients as these requirements mature. The ability to meets these expectations will directly impact a product’s success in the market, so the stakes are high.
Presented by Sharmila Sabaratnam, Managing Consultant at Navitas, this webinar will look to address the following:
- The BRM bar has been raised – a look at the drivers and the context
- Industry status today
- A model for success
- BRM framework
- Collaboration in action
- Capability requirements
- Tracking solutions
- A look to the future
For further information, or if you would like to register to attend this webinar, please contact us at: info.europe@navitaslifesciences.com
DIA’s eRegulatory and Intelligence Annual Conference
Venue: Sheraton Philadelphia Downtown Hotel, Philadelphia, PA 19103
Navitas will be at booth 110 at the DIA eRegulatory and Intelligence Annual Conference, May 11th – 13th in Philadelphia, PA. Regulatory Information Management (RIM) is a key topic in the Life Science Industry and Navitas will highlight how content management is the key component to RIM. RIM looks at regulatory issues as an end-to-end process, and content management is the cornerstone of all regulatory activities.
CDISC Europe Interchange
Venue: Congress Center Basel, Basel, Switzerland
Navitas is pleased to sponsor the CDISC Europe Interchange in Basel, Switzerland May 4th – 8th. Georgina Wood, Navitas’ Clinical Data Services practice lead, will speak about exciting new opportunities in the clinical data space concerning data warehousing with Oracle’s LSH/DMW as well as data visualization and statistical computing. Ms. Wood was formerly Global Head of Technology Innovations at Novartis.
EMC World
Venue: The Venetian. Las Vegas, NV, USA
Navitas will be presenting Regulatory Information Management (RIM) for the Life Sciences industry at EMC World Las Vegas, May 4th – 7. Life Science companies are IP driven and Navitas will demonstrate how technology, the Next Generation User Interface and process are the keys to Regulatory excellence.
Live Webinar - SMB Compliance Solution for May 2015 Deadline - US Federal Drug Supply Chain Security Act
Time: 3 PM IST
Join Axway’s leading expert, Peter Stokes and Navitas’ Associate Vice President, B Sivanandam on this timely webinar as you prepare to comply with DSCSA requirements for lot level traceability by May 1st, 2015.
View On-Demand Webinar
cmonet Meeting
Venue: Sofitel, London Heathrow T5
cmonet is a network for chief medical officers to share insights, exchange ideas, and offer peer support.
If you are interested in further information or participating at this meeting, please contact us at cmonet@navitaslifesciences.com
Women’s Life Sciences Network
Time: 18:00 – 20:45
Venue: Hyatt Regency Paris Etoile, Paris, France
Navitas Principal Consultant, Louise Jebson, will be attending the Sidley event ‘Women’s Life Sciences Network’. The event will feature a panel discussion with:
Lidia Retkowska-Mika, Co-chair, DIA EuroMeeting 2015 and Director of Legal Department, Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
Paula Salmikangas, Chair of Committee for Advanced Therapies (CAT), European Medicines Agency (EMA) & Senior Researcher, Finnish Medicines Agency (FIMEA)
Isabelle Clamou, Director, Global Regulatory and R&D policy – Europe, Amgen
If you would like more information or have any questions please contact Cristina Menendez Ruiz at cemenendezruiz@sidley.com
27th Annual DIA Euromeeting 2015
Venue: Palais des Congrès, Paris, France
Navitas Principal Consultant, Louise Jebson, will be attending the 27th Annual DIA Euromeeting as a delegate. The event this year is titled ‘Advancing Innovation to Combat the Global Burden of Disease: A Call to Action’. The meeting will address 12 themes across 5 core competencies: Clinical Development, Pharmacovigilance, Regulatory, Health Economics, and Quality and Safety
If you would like to arrange to meet with Louise, please contact us at info.europe@navitaslifesciences.com
IDMP webinar
Date: 13 April, 2015
| Time: | 16:30 – 18:00 Central European Time 10:30 – 12:00 Eastern Daylight Time 15:30 – 17:00 British Summer Time 07:30 – 09:00 Pacific Daylight Time 20:00 – 21:30 India Standard Time |
As most, if not all, pharmaceutical companies are aware, from July 2016 internally agreed terminology for the classification, retrieval, presentation, risk benefit evaluation, and assessment of pharmacovigilance and medicinal product information will become legally enforceable. These requirements apply to member states, Marketing Authorisation Holders (MAHs), and the Agency (EMA). The vehicle of choice is a set of five ISO standards, generally referred to as the Identification of Medicinal Products, or IDMP.
There is no doubt, from an objective perspective, that what IDMP proposes makes good sense. However, it does raise challenges for implementation, especially so within an industry that is under commercial pressure to cut annual budgets and reduce headcount. There are many different ways to ensure compliance with regulatory requirements, but there are only a few ways that ensure a long-term sustainable solution is in place; any solution to IDMP must be thought of holistically.
Presented by Rens van den Boomen, Senior Consultant at Navitas, this webinar will look to address the following:
- Regulatory drivers for IDMP
- What it means in reality
- IDMP Readiness – how well do you know your products?
- Roadmap to success – how to prepare and get return on your investments?
- Where next?
4th Annual Clinical Data Integration and Management
Venue: Princeton, NJ
Clinical Data Analysts from Navitas will present “Using Data Standards to Improve Efficiency in the Set – Up of Clinical Trials” at 10a.m. on March 31st. The Significance & efficiencies of CDASH in terms of traceability & consistency of d&& collaboration functionalities, and more will be covered
Oracle Industry Connect 2015
Venue: Washington Hilton, Washington DC, USA
Navitas CEO, Jim Tizzard, will be attending this Oracle event as well as being part of a panel examining how digitising data is transforming clinical trials and exploring its impact on the future of clinical development. The session, titled ‘Digital Trials and Research Models of the Future’ will be chaired by Mukhtar Ahmed, Global Vice President Life Sciences Strategy, at Oracle.
Oracle Industry Connect is a two day conference where industry peers share deep domain expertise, insights, and best practices about the mission critical applications core to their business. This event is exclusive and invitation only.
If you would like to arrange to meet with Jim, please contact us at info.europe@navitaslifesciences.com
India - TrackWise User Group (TUG)
Date: 16 March, 2015
Venue: Hyatt Regency, Mumbai
Navitas and Sparta Systems will host the first TrackWise User Group (TUG) event on 16th March 2015 at the Hyatt Regency, Mumbai. This event will serve as a platform for TrackWise users from this region to connect and share their experiences and TrackWise EQMS best practices with each other. Users can also learn from experts on how to get more from their investments in TrackWise.
PhUSE - Pharmaceutical Users Software Exchange - Mumbai
Venue: TTC Industrial Area, MIDC Navi Mumbai, India
Navitas is participating, sponsoring and presenting a session on eSubmissions – an overview in PhUSE Single Day Event. PhUSE is an independent, not-for-profit organization run by volunteers. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.
SAP TechEd Bangalore
Venue: Bangalore International Exhibition Centre
Navitas is one of the sponsor at this prestigious event. We will be showcasing our SAP certified mobility framework for Pre-Manufacturing, Plant Maintenance and Warehouse Edge System. SAP TechEd is the premier technical education conference for IT architects, administrators, and developers – offering more than 500 hours of training on SAP technology for in-memory computing, enterprise mobility, analytics, database, and the cloud.
The Economist Pharma Summit
Date: 26 February, 2015
Venue: Radisson Blu Portman Hotel, London, UK
Navitas Director, Mike Giffin, will be attending The Economist Pharma Summit as a delegate.
The event, now in its 21st year, will focus on the challenges impacting the world of pharma, as well as the innovation required to face them. The Pharma Summit will address areas such as improving access and affordability of medicines, the immense differences between developed and emerging markets, technology in pharma, and enhancing partnerships across the ecosystem to benefit all.
If you would like to arrange to meet with Mike, please contact us at info.europe@navitaslifesciences.com
Virtue Insight 8th Pharmacovigilance 2015
Venue: Marriott Marble Arch Hotel, London, UK
Navitas Managing Consultant, Sharmila Sabaratnam, will be attending Virtue Insight’s 8th Pharmacovigilance conference as a delegate.
The conference will bring together top pharmaceutical, biotechnology, and regulatory representatives to address key industry issues. The program will cover the detection, analysis, and prevention of adverse drug reactions with the aid of case studies and industry experiences.
If you would like to arrange to meet with Sharmila, please contact us at info.europe@navitaslifesciences.com
NJ CDISC Users Group Meeting
Venue: Navitas Inc., Princeton, NJ, United States
Navitas hosted this event at our US site. The attendes appreciated the quality of content presented during the event.
The event focused towards Metadata management and ADaM analysis based discussions. The meeting was also organized via web-conferencing for remote access.