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Opening Remarks and Session 1: Year in Review
Session Chair(s)
Simon Dagenais, PHD, MSC
Asset lead, Medical evidence development, Pfizer Inc, United States
This session is intended to provide an overview of recent events related to RWE in the past year, including regulatory decisions, guidance, and projects, as well as publications, guidelines, and industry activities. The session will choose a few key examples for discussion, provide a brief description of each event, place the event in a historical context to highlight what is new, and attempt op highlight key themes that may emerge in the future related to these events. This session may provide some background for other sessions that will delve into these events and themes in more depth.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe recent events related to RWE in the past year
- Discuss why these recent events are important to RWE
- Identify new events in context of existing information on the topic
Speaker(s)
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
FDA Guidance related to RWE
Nirosha M. Lederer, PHD, MS
Head, US Government Partnerships; Senior Director, RWE Strategy, Aetion, United States
Recent Examples of RWE Submissions
Shirley Wang, PHD, MSC, FISPE
Associate Professor of Medicine, Harvard Medical School, United States
Update on RWE Reporting Quality
Jessica Franklin, PHD
Principal Consultant, Epidemiology and Real-World Evidence , Optum, United States
Update on RCT DUPLICATE Project
Dan Gebremedhin, MD, MBA
Partner, Flare Capital Partners, United States
Financial Trends in the RWE Industry
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