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Global Events

Renaissance London Heathrow Hotel

Oct 09, 2018 8:00 AM - Oct 10, 2018 5:30 PM

Bath Road, Hounslow, Middlesex, TW6 2AQ, United Kingdom

Value, Access, and Regulatory Strategy Conference

Paving the Way to the Future by Building Bridges

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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, Science & 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)

Nanna Borup Johansen

Senior Medical Officer, Danish Medicines Agency, Denmark

Update on HMA/EMA Big Data Taskforce

Hannah Patrick

Consultant Clinical Adviser, Observational Data Unit, National Institute for Health and Care Excellence (NICE), United Kingdom

NICE experience of evidence generation using registers

Chris Chinn, MSC

Real World Evidence for Market Access, Sanofi, United Kingdom

Learnings from IMI GetREAL

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