Sixteenth Annual Sentinel Initiative Public Workshop

On November 7, 2024, the Duke-Margolis Institute for Health Policy will host the 16th Annual Sentinel Initiative Public Workshop under a cooperative agreement with the United States Food and Drug Administration (FDA). The workshop will be a hybrid event, with in-person and virtual attendance. Attendees will have the opportunity to discuss recent achievements and developments and engage with the broader community, including patients, consumers, and researchers.

The Sentinel Initiative was launched in response to the Food and Drug Administration Act of 2007 (FDAAA) and Congressional mandate that FDA develop a national electronic system to track the safety of regulated medical products. Since its inception, the Sentinel Initiative has continued to refine and expand its data infrastructure capabilities. In recent years, new analytical tools and methodological enhancements have unlocked greater access to diverse data sources, which improves the quality of evidence for safety surveillance operations.

This hybrid, public workshop will feature a keynote from Patrizia Cavazzoni, Director of the FDA's Center for Drug Evaluation and Research. Participants will also hear from Sentinel Initiative leadership on a range of key issues illustrated by exemplary use cases. Sessions will consider key progress made in--and upcoming opportunities for--the Sentinel System, BEST System, and the landscape of community engagement.

Acknowledgement of Funding

This event in supported by the FDA of the U.S. Department of Health and Human Services (HHS) as a part of a financial assistance award U01FD006807 totaling $3,493,089 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official view of, nor an endorsement by, FDA/HHS or the U.S. Government.