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Session 1: A Year in Review
Session Chair(s)
SARAH K Martin, PhD, MS
Senior Director - Global Regulatory Policy (Oncology)
Eli Lilly & Co., United States
The session will explore new key milestones and major events in Real-World Evidence (RWE) since last year. The first presentation will provide a broad global overview of remarkable advances in RWE. The second presentation will summarize FDA’s RWD/E guidances on drugs and biologics products and highlight the draft non-interventional study guidance, provide an update on RWE commitments for PDUFA VII, and offer insights on how FDA centers are leveraging RWE. The third presentation will discuss applications of RWE in FDA Sentinel, including the scope and progress of projects in the RWE Data Enterprise and Sentinel’s PDUFA VII demonstration projects. The session will conclude with a panel discussion and audience Q&A.
Learning Objective : - Discuss draft and final guidances on RWE from US FDA including draft guidance on non-interventional studies
- Describe FDA’s Sentinel demonstration projects
- Recognize notable advances in RWE over the past year
Speaker(s)
Speaker
Gabriel I Innes, DVM, PhD
FDA, United States
Health Science Policy Analyst, OMP, CDER
Sarah Dutcher, PhD, MS
FDA, United States
Lead Epidemiologist, OSE, CDER