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Session 1: A Year in Review
Session Chair(s)
Sarah Martin, PhD, MS
Senior Director - Global Regulatory Policy (Oncology)
Eli Lilly & Co., United States
The session will explore key milestones and major events in Real-world Evidence (RWE) over the past 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Learning Objective : - Discuss draft and final guidances on RWE from US FDA including draft guidance on non-interventional studies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)
![Representative Invited](/_Images/member/Generic_Image_Missing-Profile.jpg)
Speaker
Representative Invited
FDA, United States
![Representative Invited](/_Images/member/Generic_Image_Missing-Profile.jpg)
Representative Invited
FDA, United States
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