Global Pharmaceutical Regulatory Affairs Summit
Venue: Hotel Palace Berlin, Berlin, Germany
Navitas Life Sciences are both speaking and exhibiting at stand #8 at the Global Pharmaceutical Regulatory Affairs Summit. The event looks at where Regulatory meets eRegulatory – bringing answers to the pharmaceutical industry and enabling companies to take their strategy to the next level with leading advice from Regulatory Authorities, Key Stakeholders, and global perspectives. The event will address three main areas: Global eSubmissions, Regulatory Information Management (RIM), and Regulatory Affairs in Global Markets.
Navitas Life Sciences’ Global Head of Regulatory and Safety, Marty Boom, will be presenting a session titled: Enhancing the overall efficiency of global Regulatory Information Management
This session will look at:
- Industry challenges associated with managing global Regulatory information
- Tackling the over processing of data using multiple systems
- Showcasing process and data integration of end-to-end Regulatory Information Management to enhance efficiency
If you would like to meet with one of our subject matter experts onsite, then please click here to schedule a meeting.
For further information about the conference, please visit the event website at: https://informaconnect.com/global-pharmaceutical-regulatory-affairs/
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 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 This email address is being protected from spambots. You need JavaScript enabled to view it.
pvconnect Forum - Spring
Venue: New York, USA
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘Optimizing PV in 2020 and beyond’ and will focus on the following:
- Industry context
- Optimizing inspection readiness
- The emerging PV organization
- Advances in digital PV
labelnet Forum - Spring
Venue: New York, USA
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘Labeling – Patients, People, and Value’ and will focus on the following:
- Latest labeling landscape – industry and regulations
- Workforce strategy – now and future
- Strategic labeling and value proposition
- Outside-in labeling: A patient perspective
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
pvtech Forum - Spring
Venue: New York, USA
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘PV 2020 – 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 This email address is being protected from spambots. You need JavaScript enabled to view it.
labeltech Forum - Spring
Venue: New York, USA
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘The art of the possible – beyond tracking’ and will focus on the following:
- Latest technology landscape
- The art of the possible – what is out there?
- Automation driven technology implementation
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
pvnet Summit - Spring
Venue: New York, USA
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘PV2020 – Embracing Patient-to-Patient Safety’ and will focus on the following:
- Industry context
- Engaging patients with impact
- Benefit Risk Management – novel therapies
- From ‘Doing to Being Digital’
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
labelconnect Forum - Spring
Venue: New York, USA
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘Do more with less’ and will focus on the following:
- The regulatory landscape
- What is the core label?
- Flexible labeling workforce
- Seamless end-to-end tracking
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
rimnet Forum - Spring
Venue: New York, USA
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 June agenda will be released shortly.
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
pvconnect Forum - Spring
Venue: London, UK
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘Optimizing PV in 2020 and beyond’ and will focus on the following:
- Industry context
- Optimizing inspection readiness
- The emerging PV organization
- Advances in digital PV
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
labelnet Forum - Spring
Venue: London, UK
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘Labeling – Patients, People, and Value’ and will focus on the following:
- Latest labeling landscape – industry and regulations
- Workforce strategy – now and future
- Strategic labeling and value proposition
- Outside-in labeling: A patient perspective
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
pvtech Forum – Spring
Venue: London, UK
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around PV 2020 – 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 This email address is being protected from spambots. You need JavaScript enabled to view it.
labeltech Forum - Spring
Venue: London, UK
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around ‘The art of the possible – beyond tracking’ and will focus on the following:
- Latest technology landscape
- The art of the possible – what is out there?
- Automation driven technology implementation
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
pvnet Summit – Spring
Venue: London, UK
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around PV 2020 – Embracing Patient-to-Patient Safety and will focus on the following:
- Industry context
- Engaging patients with impact
- Benefit Risk Management – novel therapies
- From ‘Doing to Being Digital’
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
labelconnect Forum – Spring
Venue: London, UK
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 Spring agenda is themed around Do More With Less and will focus on the following:
- The regulatory landscape
- What is the core label?
- Flexible labeling workforce
- Seamless end-to-end tracking
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
rimnet Forum - Spring
Venue: London, UK
In response to COVID-19 and to fully protect our members, team, and the public, we can confirm that our Spring Network Forums scheduled for June will now 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 June agenda will be released shortly.
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
Navitas Life Sciences Live Webinar: Enhancing the overall efficiency of global Regulatory Information Management
Time: 10:00 – 11:00 EST
Join our subject matter experts for a live webinar as they discuss enhancing the overall efficiency of global Regulatory Information Management (RIM).
This webinar will explore:
- Industry challenges associated with managing global Regulatory information
- Optimizing data handling across multiple regulatory systems
- Showcasing process and data integration of end-to-end Regulatory Information Management to enhance efficiency
Presenters:
- Mayank Raizada, Senior Managing Consultant, Navitas Life Sciences
- Chikkam Rama Mohan Rao, Global Regulatory Business Partner, Navitas Life Sciences
To register for this webinar, please click here.
Navitas Life Sciences Live Webinar: Impact of EU MDR on Device and Combination Product Surveillance and Labeling
Time: 10:00 – 11:00 EST
Join our subject matter experts for a live webinar as they discuss the impact of EU MDR on Device and Combination Product Surveillance and Labeling.
This webinar will explore:
- The regulatory drivers and timelines
- Latest EU MDR Update
- Impact on product Surveillance and Labeling
- Implications of new regulatory requirements
- Surveillance Insights: Industry insights on implementing Device and Combination Product Surveillance Requirements
- Labeling Insights: Industry insights on implementing Device and Combination Product Surveillance Requirements
- Approach: Developing a holistic solution - People, Process, and Technology
- Governance can bind Process, Organization, and Compliance
- Procedures and Systems should allow for Transfer of Quality and Safety information with clear triggers
Presenters:
- Mayank Raizada, Senior Managing Consultant, Navitas Life Sciences
- Josefine Sommer, Senior Associate, Sidley Austin LLP
To register for this webinar, please click here.
cmonet Meeting (CANCELLED)
Venue: Bayer Offices, Whippany, NJ, USA
Please be advised that due to increasing global concern regarding the coronavirus outbreak, and resultant travel risk, we have decided to postpone the cmonet meeting. Please accept our apologies for any inconvenience caused. The event will be rescheduled, with further information to follow.
cmonet is a network for Chief Medical Officers, addressing strategic and governance topics with the remit of the CMO.
Please be advised that this is an invitation only event.
For further information please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.
PHUSE US Connect 2020
Venue: Renaissance Orlando at SeaWorld, Florida, USA
On Tuesday 10 March between 13:30 – 14:00, Navitas Life Sciences’ Global Head of Consulting, John D’Antonio, will be taking to the podium to present a session titled: OneClinical Analytics for High Performance Trials – Moving from Data to Actionable Insights.
With the increasing complexity and volume of clinical trial data there is a real challenge with oversight and ensuring a timely decision-making process. John will present OneClinical, a solution that goes beyond just the standard operational analytics and provides tailor-made real-time study level analytics which are based on specific study protocol. For clinical trials this enables faster, more informed decision-making and remediation before mistakes become systemic. By making analysis more accessible and faster, OneClinical drives critical collaboration and better decision-making throughout the trial. It has the best clinical intelligence and analytical depth to be a powerful weapon in a trial managers arsenal.
Our colleagues at Navitas Data Sciences will also be exhibiting at Stand #23
If you would like to meet with one of our subject matter experts onsite and learn how you can improve your Clinical Trial Outcomes, then please click here to schedule a meeting.
For further information about the conference, please visit the event website at: https://www.phuse.eu/us-connect20
pvindia Forum - Spring (CANCELLED)
Venue: Mumbai, India
Please be advised that due to increasing global concern regarding the coronavirus outbreak, and resultant travel risk, we have decided to postpone the pvindia meeting. Please accept our apologies for any inconvenience caused. The event will now take place on 14 October, 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.
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 This email address is being protected from spambots. You need JavaScript enabled to view it.
BioAsia 2020 conference
Venue: Hyderabad International Convention Centre (HICC), Hyderabad
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.
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 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: This email address is being protected from spambots. You need JavaScript enabled to view it.
ISCR CONFERENCE 2020
Venue: Taj Lands End, Mumbai
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.
JP Morgan Healthcare
Venue: Westin St. Francis Hotel, San Francisco, California
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 On-Demand Webinar: Enhancing the overall efficiency of global Regulatory Information Management
Join our Subject Matter Experts as they discuss enhancing the overall efficiency of global Regulatory Information Management (RIM).
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar: Managing the Operational Challenges of COVID-19 Clinical Trials
In our new normal, driven by COVID-19, we appreciate that there is pressure on pharma companies to accelerate therapeutic drug development for patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as well as a vaccine for its prevention.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar: Are you prepared for the new EU Medical Device Regulation (MDR) requirements?
Join our subject matter experts for a live webinar as they discuss the impact of EU MDR on Device and Combination Product Surveillance and Labeling.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar: 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.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar: Will you be ready to comply with DSCSA Verified Router Services?
Join serialization experts as they explore the VRS requirement and discuss strategies and activities companies can take to comply with the guideline as well as future-proof their supply chain for any future serialization regulatory requirements.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar: Leveraging Technology for Improved Outcomes across End-to-End Labeling
Join our subject matter experts as they examine how leveraging technology can improve outcomes across your End-to-End Labeling processes.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar Clinical & Regulatory Data Convergence: Increasing Enterprise Value
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.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar EU FMD Compliance: Are You READY?
This webinar discussed how you can speed up your efforts to meet the EU FMD deadline with innovative industry leading technology.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar: RIM Maturity Model: A strategic path to next-generation Regulatory Information Management
Register to view our on-demand as we explain how the RIM Maturity Model has been crafted into an excellent tool to determine your organization’s current level of RIM maturity across levels 1-5; and share our experiences in using the model in real world cases.
View On-Demand Webinar Navitas Life Sciences On-Demand Webinar: The building blocks of successful outcomes in Data-Driven Clinical Trials
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.
View On-Demand Webinar Navitas Networks On-Demand Webinar & Slides: EudraVigilance - Handling the far reaching and diverse impact on changes to EV system
Hosted by Navitas Networks this webinar is presented by Denis Fung and Zuby Okemefuna from Navitas Life Sciences. The webinar addresses the following:
- The current outsourcing landscape
- Determining what should be outsourced and what should remain in-house
- The challenges of outsourcing and key issues to be aware of
- Key success factors
- How to de-risk the transition
View On-Demand Webinar
Navitas Networks On-Demand Webinar & Slides: EudraVigilance - Handling the far reaching and diverse impact on changes to EV system
Hosted by Navitas Networks this webinar is presented by Mayank Raizada from Navitas Life Sciences.
The webinar addresses the following:
- The New EV System
- Temperature check on EV Changes
- Summary
View On-Demand Webinar
Navitas Networks On-Demand Webinar & Slides: PSP Management
Hosted by Navitas Networks this webinar is presented by Kimberly Kotlar, Director, Organized Data Collection (ODC), Center of Excellence (CoE), Pharmacovigilance & Patient Safety (PPS), AbbVie, Jody Trieloff, Associate Director,Pharmacovigilance and Patient Safety Data Management - AbbVie and Marie-Claire Wilson Senior Project Manager from Navitas Life Sciences.
The webinar addresses the following:
- The rise of MRPs/PSPs
- A reflection on company experiences
- So what and where next?
View On-Demand Webinar
On-Demand Webinar: BA/BE Studies Best Practices – Gaining the First to File Advantage
Watch this recorded webinar to learn about new, evolving industry best practices that reduces a company’s time to market while adhering to constantly changing regulatory issues, as well as learning how quality and cost efficiencies have evolved due to technological advances.
View On-Demand Webinar
Navitas Networks On-Demand Webinar: GVP Module IX update – Impact beyond borders
Hosted by Navitas Networks this webinar was presented by Jeffrey Ho, Principal, Navitas Life Sciences & Louise Tan, Consultant, Navitas Life Sciences.
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
View On-Demand Webinar
Navitas Networks On-Demand Webinar & Slides: RIM Maturity Pathway – achieving your RIM goals using the RIM Maturity Model
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.
The webinar addresses the following:
- 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
View On-Demand Webinar
On-Demand: Navitas webinar series on ICH E6 GCP compliance
2nd webinar of the series: Introducing ICH compliant RBM to your Clinical Trials Webinar
Hosted by Navitas Networks this webinar is presented by Andy Lawton Consultant and Director of Risk Based Approach Ltd and Janet Fernihough, Senior Consultant at Navitas Life Sciences.
The webinar addresses the following:
- 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
View On-Demand Webinar
Navitas Networks On- Demand Webinar On: Labeling Organization – Simplicity or Specialism?
Hosted by Navitas Networks this webinar is presented by Denis Fung from Navitas Life Sciences.
The webinar addresses the following:
- 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
View On-Demand Webinar
Navitas Networks On-Demand Webinar & Slides – End to End Labeling Technologies – Looking Forward
Hosted by Navitas Networks this webinar is presented by: Govind Srinivasan, VP & Technology Head, Midhun Kiriyan, Managing Consultant, Jim Chesterman, Managing Consultant and Zuby Okemefuna, Senior Consultant
The webinar addresses the following:
- What is
- 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
View On-Demand Webinar
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)
Hosted by Navitas Networks this webinar is presented by Andy Lawton, Consultant and Director of Risk Based Approach Ltd and Janet Fernihough, Senior Consultant at Navitas Life Sciences.
The webinar addresses the following:
- What is Quality by Design?
- What can we learn about Quality by design from the manufacturing industry?
- Applying Quality by Design learning in manufacturing to clinical trial management
View On-Demand Webinar
Navitas Networks On-Demand Webinar & Slides : The safety database in a pharma company – tactical considerations for delivering on compliance and efficiency
Hosted by Navitas Networks Webinar this webinar is presented by Martin Holms-Petersen, Senior Consultant and Head of pvtech Navitas Life Sciences.
The webinar addresses the following:
- 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
View On-Demand Webinar
Navitas Networks On-Demand Webinar & Slides: E2E labeling – Achieving Global Consistency
Hosted by Navitas Networks this webinar is presented by Tara Baer.
The webinar addresses the following:
- The Global labeling Context
- Building Global connections
- Looking forward
View On-Demand Webinar
Navitas and Sparta Systems - On-Demand webinar - Ensuring Data Integrity, Mitigating Risk and Quality Metrics
This webinar addresses 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
View On-Demand Webinar
Navitas Networks On-Demand Webcast & Slides: IDMP – Getting Ready
Hosted by Navitas Networks this webinar is presented by Navitas’ Senior Consultant Gary Aldam.
The webinar addresses the following:
- The evolving IDMP regulatory landscape
- How does industry prepare?
- Getting Ready for IDMP
- Looking forward
View On-Demand Webinar
Navitas Networks and AbbVie On-Demand Webcast & Slides – PV Organisations Reimagined – Roadmap to transforming into a strategic PV organisation
Hosted by Navitas Networks and AbbVie, this webinar is 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.
View On-Demand Webinar
Navitas’ pvindia On-Demand Webcast: Getting Inspection Ready
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’.
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On-Demand Webcast & Slides: Next Generation PV Tools
Hosted by Navitas Networks, this webcast is presented by Navitas’ Senior Consultant, Martin Holm-Petersen. The webcast will address the following:
- IT as the game changer
- What does digitally transformed PV look like?
- Building IT strategies for PV
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On-Demand Oracle Webinar Series: Application Management Services
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.
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On-Demand Oracle Webinar Series: Increase your upgrades to reduce your cost and complexity
The right strategy for upgrading your Argus safety database will save you money, effort and ensure that you have a system that fully supports your business needs and objectives. In this webinar we will talk you through Navitas’ forward thinking approach to system upgrades.
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On-Demand Oracle Webinar Series: Data Migration
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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On-Demand Oracle Webinar Series: Accelerated Argus Implementations
Navitas has been working with the Safety departments of the world’s leading pharmaceutical companies through consulting and our pvnet & pvconnect for over 15 years. We have used our unique insight to develop industry leading accelerators that automatically configure the Argus Safety application to significantly reduce implementation times.
This webinar will explain how our accelerators can fast track your Argus implementation whilst ensuring it is tailored to your specific business requirements.
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On-Demand Oracle Webinar Series: Oracle Argus in the Cloud
More and more companies, both small and large, are moving to the cloud, but it’s important you choose the right hosted environment for your business. This webinar will talk you through the advantages of cloud implementations, our expedited approach to implementation and the options open to you.
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On-Demand Webcast & Slides: End-to-End Labeling Tracking Tools in Action
Hosted by Navitas Networks, this webcast was 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 labeling
- Tracking tools in action
- Looking forward
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Webcast Slides: IDMP - IDentification of Medicinal Products From concept to reality
Hosted by Navitas Networks, this webcast was 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
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On-Demand Webinar: Content Management in Minutes: Legal Contract Management - Navitas and Generis
Control your contracts by leveraging the power of metadata. Register to view: A dashboard of upcoming contract renewals, determine the value of what is ahead combined with the workload and the resources needed. The capabilities of creating contracts easily from templates and populating specific contract variables (vendor name, ID and so on) into the Word document on creation.
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On-Demand Webinar: Content Management in Minutes: Human Resource Management - Navitas and Generis
Take your HR environment to the next generation while leveraging your current content management investment. Register and watch a brief 30-minute session on Content Management in Minutes: Human Resource Management.
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On-Demand Webinar: Content Management in Minutes: Quality - Navitas and Generis
Register and see how you can manage your standard operating procedures (SOP), work instructions, specifications, analytical methods and other quality-related documents in a simple yet powerful user interface.
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On-Demand Webinar: Content Management in Minutes: Correspondence Management - Navitas and Generis
Register and watch how you can 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.
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On-Demand Webinar: Content Management in Minutes: Mobile Access - Navitas and Generis
Register to view demonstration showing interaction between a user on a desktop client 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.
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On-Demand Webinar - Content Management in Minutes: Electronic Trial Master File (eTMF) - Navitas and Generis
Register to 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.
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Webinar Slides: IDMP - Identification of Medicinal Products IDMP Readiness Revisited – Where Next?
Hosted by Navitas Networks this webinar is presented by Jeffrey Ho & Rens van den Boomen. This presentation slides 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?
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Webinar Slides: End-to-End Labeling – New Frontiers
Label management is a complex activity that is on-going throughout the lifecycle of a pharmaceutical product. Effective labeling, 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 labeling oversight is now a regulatory expectation and no longer just a future requirements.
Register to download webinar presentation slides held on July 01, 2015.
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SMB Compliance Solution for May 2015 Deadline - US Federal Drug Supply Chain Security Act
Register and view this on-demand Webinar where we will discuss the requirements and challenges for compliance with the US Federal Drug Supply Chain Security and Axway’s solution, especially tailored to the requirements of Small and Medium Businesses.
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How to reduce the cost and complexity of complying with chain of custody and track and trace regulations including DQSA
Greater Compliance and Risk reduction are key considerations for Pharma companies worldwide. Advancements in technology and mobility solutions have created new avenues for pharmaceutical companies to improve business performance. However, leveraging mobility to reduce risk & increase compliance is an area that is still in its infancy!
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Process excellence & compliance through enterprise mobility solutions
Register to listen Axway’s leading expert, Atif Chaughtai and Navitas’s head of implementation, B Sivanandam as you prepare to comply with DSCSA requirements for lot level traceability...
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CARA for Documentum & Alfresco in the Cloud
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum & Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the final chapter in a six-part series showcasing CARA as the next generation user interface, and now in the cloud!
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CARA for Regulatory Information Management
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the fifth in a six-part series showcasing CARA as the next generation user interface.
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CARA for eTMF
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the fourth in a six-part series showcasing CARA as the next generation user interface.
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CARA for Regulatory Affairs and Submission Management
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the third in a six-part series showcasing CARA as the next generation user interface.
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CARA for Controlled Content / Quality Document Management
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the second in a six-part series showcasing CARA as the next generation user interface.
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The next generation user interface for Documentum and Alfresco
Register to view how we can provide a rapid implementation of the fastest, most configurable and feature-rich user interface to meet the needs of Documentum and Alfresco users who are currently using legacy interfaces or applications, and are looking to reduce costs and speed up use case implementation. This is the first in a six-part series showcasing CARA as the next generation user interface.
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