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.

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 #8 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 click here to schedule a meeting.

For further information about the event, please visit the event website here.

Navita Life Sciences will be at the Global Bio India 2019, to be held in India for the first time at Aerocity, New Delhi. This event is conducted by BIRAC and DBT of Ministry of Science and Technology. The event is being organized to showcase the plethora of services provided by the Indian Biotechnology sector to the world.

Meet our experts Ram Yeleswarapu (President, Navitas Life Sciences) and Koushik Ganguly (VP Clinical Operations, Navitas Life Sciences) to discuss how our transformative solutions could cater to your unique needs and challenges in the biopharmaceutical industry. Please visit our talk during Session 25 on Bio-Services Industry to be conducted on day 2, 22nd Nov 2019, between 3:30 pm and 4:25 pm.

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; 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 click here to schedule a meeting.

For further information about the event, please visit the event website here.

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.

This webinar will examine:

• The DSCSA VRS Guidance and Serialization Data Requirements
• The overall purpose and need of a VRS System
• An up to date Industry benchmark
• Steps that you can take now to comply with the guidelines
• Onboarding options available for Manufacturers and Distributors
• Explore options for a VRS outside your Serialization Database Vendor 
• Extending Edge solution to use VRS for Returns verification
• Expanding to other Global Serialization Requirements such as EU FMD and Russia’s Markirovka

Presenters:

• Govind Srinivasan, Vice President, Technology at Navitas Life Sciences
• Stephen Mclndoe, Vice President, Consulting at Be4ward LTD

To register for this webinar, please click here

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

You will find Navitas Life Sciences next at Conspic 2019, one of the largest conclaves in Indian clinical research industry. We are one of the official partners and we will be presenting papers to provide greater insight into the Indian clinical research industry. The conference will be held between Nov 11th to 13th 2019 at Radisson Blu Resort, Cavelossim Beach, Goa, India.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Navitas Life Sciences are pleased to be attending and exhibiting at Stand 121A56 at the upcoming CPhI Worldwide conference. The event is the world’s largest pharmaceutical exhibition, representing every stage of the pharmaceutical supply chain.

If you would like to meet with our subject matter experts onsite to discuss how you can utilize Navitas Life Sciences’ experience of over 100 marketing approvals 3 state-of-the-art facilities, Zero Refusal to File reports, and more than 250 validated bioanalytical methods and leverage our experience to gain first-to-market advantage, then please click here.

For further information about the event, please visit the event website here.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 click here 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. 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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 click here 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 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 This email address is being protected from spambots. You need JavaScript enabled to view it. 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. 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.

We are proud to have more than 120,000 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 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 This email address is being protected from spambots. You need JavaScript enabled to view it. 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’ (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. 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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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

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.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

For further information about the conference, please visit the event website at: https://www.q1productions.com/regops/

Navitas Life Sciences’ Client Partner, Vencislav Cheshmedzhiev, will be attending the 13^th 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 This email address is being protected from spambots. You need JavaScript enabled to view it.

For further information about the conference, please visit the event website at: https://www.virtueinsight.com/pharma/13th-Biosimilars-Congregation-2019/

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

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.

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

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 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

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 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

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 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

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.

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

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 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

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 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 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

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 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

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 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

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.

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

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 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

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.

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

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 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

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’ 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 This email address is being protected from spambots. You need JavaScript enabled to view it.

For further information about the conference, please visit the event website here

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

Navitas Life Sciences’ Dawne Nanada, Senior Managing Consultant, will be in attendance at this event. If you would like to arrange to meet with Dawne please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it..

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

For further information about the conference, please visit the event website at: http://www.arena-international.com/octeurope/

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.

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

For further information about the conference, please visit the event website at: https://lifesciences.knect365.com/eregulatory-summit/

If you would like to meet with a member of our team please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 7^th forum, which will include:

• Context and Regulatory update
• PV today – moving towards operational excellence
• Automation and how it fits into the PV evolution

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.

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

The webinar will provide a framework for NextGen PV Technology Transformation.

Presenter:
Rekha Illuri, Senior Managing Consultant, Navitas Life Sciences

To register for this webinar, please click 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’

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

For more information, visit here

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

For further information about the event please contact Cristina Menendez Ruiz at This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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

We will also be exhibiting at the event and look forward to meeting you at Booth D5 to discover how we can transform your Clinical Trials through our Insights and Data-Driven Clinical Solutions that are customized to address your critical challenges. To arrange a meeting with our subject matter experts please click here

For further information, please visit the event website here

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

We will also cover some near-term strategic steps that can be taken to address challenges and advance enterprise value.

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 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 rimnet November agenda is themed around ‘Defining effective RIM’ and will focus on the following:

• The latest RIM context and Regulatory updates
• Implementing risk based global processes
• Systems integration

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.

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 pvnet November agenda is themed around ‘Modern PV: People, Tools, and Metrics’ focusing on:

• The latest Regulatory insights
• PV automation
• PV workforce of the future
• Vendors, value, and how to measure success

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 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

The labelnet November agenda is themed around ‘Labeling Nirvana’ and will focus on the following:

• Regulatory insights and Reference Labeling
• Development Labeling – what does good look like?
• How to build a business case for strategic labeling

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 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

The labelconnect November agenda is themed around ‘Next Generation Labeling’ and will focus on the following:

• Regulatory insights and Reference Labeling
• Labeling for different sectors: Devices, Combination Products, Biosimilars, and Consumer Products
• Next generation competencies and resourcing

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 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

Technology will be a key feature of this event with discussions taking place around future focused technologies vs. today’s technologies

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.

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

The pvconnect November agenda is themed around ‘Enduring themes, new perspectives’ and will explore:

• Regulatory update
• Vendor management – new perspectives
• Benefit Risk management – future focus
• Leveraging data and technology

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.

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 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

The labelnet November agenda is themed around ‘Labeling Nirvana’ and will focus on the following:

• Regulatory insights and Reference Labeling
• Development Labeling – what does good look like?
• How to build a business case for strategic labeling

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 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

The labelconnect November agenda is themed around ‘Next Generation Labeling’ and will focus on the following:

• Regulatory insights and Reference Labeling
• Labeling for different sectors: Devices, Combination Products, Biosimilars, and Consumer Products
• Next generation competencies and resourcing

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 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 rimnet November agenda is themed around ‘Defining effective RIM’ and will focus on the following:

• The latest RIM context and Regulatory updates
• Implementing risk based global processes
• Systems integration

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 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

Technology will be a key feature of this event with discussions taking place around future focused technologies – combined with a parallel pvtech meeting

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.

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

The pvconnect November agenda is themed around ‘Enduring themes, new perspectives’ and will explore:

• Regulatory update
• Vendor management – new perspectives
• Benefit Risk management – future focus
• Leveraging data and technology

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.

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 pvnet November agenda is themed around ‘Modern PV: People, Tools, and Metrics’ focusing on:

• The latest Regulatory insights
• PV automation
• PV workforce of the future
• Vendors, value, and how to measure success

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.

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

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 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 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.

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

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

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:

1. Process
2. Governance
3. Data
4. Technology
5. Culture

Join us 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.

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.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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

To register to attend, please click here

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.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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.

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.

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.

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

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.

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
• Inspection Readiness in a shifting global context
• Smart solutions to everyday complexities

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 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

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.

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

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.

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

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.

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

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 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

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.

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

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.

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
• Inspection Readiness in a shifting global context
• Smart solutions to everyday complexities

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.

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?

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.

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

To register to attend this webinar please click here.

For further information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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/

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.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 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

Navitas Life Sciences will be in attendance at this event and taking part in the partner showcase.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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

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

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.

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

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

Speaker: Mayank Raizada, Managing Consultant, Navitas Life Sciences

To register for this event, please click

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

Navitas Life Sciences’ Principal Consultant, Jeff Ho, will be presenting a session on EudraVigilance. For further information or to arrange to meet with Jeff please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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/

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

Speaker: Mayank Raizada, Managing Consultant, Navitas Life Sciences

Registration page link: http://inform.navitaslifesciences.com/af2?LinkID=CH00097058eR00000253A

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 This email address is being protected from spambots. You need JavaScript enabled to view it..

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

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