戻る Agenda
Opening Remarks and Session 1: Year in Review
Session Chair(s)
Simon Dagenais, PhD, MSc
Real-World Evidence Lead, Internal Medicine
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)
FDA Guidance related to RWE
John Concato, MD, MPH, MS
FDA, United States
Associate Director for Real-World Evidence Analytics, OMP, CDER
Recent Examples of RWE Submissions
Nirosha M. Lederer, PhD, MS
Aetion, United States
Head, US Government Partnerships; Senior Director, RWE Strategy
Update on RWE Reporting Quality
Shirley Wang, PhD, MSc, FISPE
Harvard Medical School, United States
Associate Professor of Medicine
Update on RCT DUPLICATE Project
Jessica Franklin, PhD
Optum, United States
Principal Consultant, Epidemiology and Real-World Evidence
Financial Trends in the RWE Industry
Dan Gebremedhin, MD, MBA
Flare Capital Partners, United States
Partner