Real-World Evidence Conference

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.