Session-6-Developments-in-Other-Regions

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Session 6: Acceptance of Evidence in Decision Making – Focus on RWE from Post-Launch Environment for Regulatory Decisions

Session Chair(s)

Angelika Joos, MPharm

Executive Director, Global Regulatory Policy

MSD, Belgium

The session will discuss how data from post-approval product development and monitoring can be used during the product life cycle to support evidence generation for decision making in the regulatory environment. What should developers consider when designing their post-approval development programs to maximise evidence available for different stakeholders? How to reconcile the different expectations into a global post-approval safety and effectiveness program that can fulfil regulatory standards and respond to HTA demands?

Real world data and evidence hold great potential for filling these gaps in knowledge. Recently, the US FDA and the EMA have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Speakers in this session will share the latest developments in this space and provide insights into the future direction.

Speaker(s)

Update on HMA/EMA Big Data Taskforce

Nanna Borup Johansen

Danish Medicines Agency, Denmark

Senior Medical Officer

NICE experience of evidence generation using registers

Hannah Patrick

National Institute for Health and Care Excellence (NICE), United Kingdom

Consultant Clinical Adviser, Observational Data Unit

Learnings from IMI GetREAL

Chris Chinn, MSc

Sanofi, United Kingdom

Real World Evidence for Market Access

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