Back to Agenda
Session 1: A Year in Review
Session Chair(s)
Simon Dagenais, PHD, MSC
Asset lead, Medical evidence development, Pfizer Inc, United States
This opening session will provide an overview of key recent events related to RWE in the past year (2021-2022) and help set the stage for more detailed discussions about these events throughout the 2022 DIA RWE Conference. This session will place events in a historical context, describe how they build on previous events, and provide a framework for understanding the recent evolution of RWE. This session will focus primarily on the following groups of stakeholders:
- Biopharmaceutical companies who analyze RWD and develop RWE
- Regulatory agencies who review and make decisions based on RWE
- Academic researchers who propose methods and standards for RWE
- Vendors who collect, disseminate, and analyze RWD
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify key events related to RWE in the past year
- Place these events in a historical context to describe how they build on previous events
- Understand how these events are interrelated and contribute to the advancement of RWE
Speaker(s)
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Overview of Recent FDA Activities Related to RWE
Shirley Wang, PHD, MSC, FISPE
Associate Professor of Medicine, Harvard Medical School, United States
Recent Findings from RCT DUPLICATE Demonstration Project
Jennifer Christian, PHARMD, PHD, MPH, FISPE
Chief Scientific Officer, Target RWE, United States
Overview of RWE Alliance
Nicholaas Honig, JD
Senior Regulatory Counsel, Aetion; Representing, Aetion, United States
Recent FDA Approvals of Submissions with RWE
Have an account?