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Welcome, Opening Remarks, and Session 1: International Updates on RWE in Regulatory Decision Making
Session Chair(s)
Nancy Dreyer, MPH, FISPE
Founder, Dreyer Strategies LLC, United States
Debra Schaumberg, DRSC, MPH
Vice President and Global Head, Startegic Development Consulting Chair, Evidera | PPD, United States
The advent of the global pandemic of COVID-19, and the resulting imperative for rapid evidence generation, has catapulted conversations around the role of RWE in regulatory decision-making, resulting in both answers and more questions about when RWE is fit-for-use; including retractions of RWE-based manuscripts from major medical journals. This session will bring together regulatory leaders from the United States, Europe, and Japan to discuss recent lessons learned about RWE and its application to the regulatory context, and the frameworks being developed to interrogate such evidence and inform when it can be trusted.
Learning Objective : - Describe the current regulatory perspectives on benefits and challenges of using RWE in regulatory decisions
- Identify challenges to use of RWE in different contexts (e.g. pre- and post-approval), and key factors considered for discriminating between RWE that can and cannot be trusted
- Compare regulatory frameworks for consideration of RWE in regulatory decision-making in three major geographies of importance to the pharmaceutical community (US, EMA and Japan)
Speaker(s)
Robin M. Weinick, PHD
SVP/Managing Director Americas and Global Program Officer, DIA, United States
Welcome and Opening Remarks
Amy Abernethy, MD, PHD
President of Clinical Studies Platforms, Alphabet’s Verily, United States
Speaker
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Speaker
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker
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