FDA Convening 15th Annual Sentinel Initiative Public Workshop
On November 8, 2023, the Duke-Margolis Center for Health Policy will host the 15th Annual Sentinel Initiative Public Workshop under a cooperative agreement with the Food and Drug Administration (FDA). The workshop will be held as a hybrid event, with in-person and virtual attendance, and will provide an opportunity for attendees to discuss recent achievements and developments as well as engage with the broader community of patients, consumers, and scientific stakeholders.
The Sentinel Initiative was launched in response to the Food and Drug Administration Amendments 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 and capabilities. In recent years, new analytical tools and enhancements to data methods have unlocked access to more diverse sources of data to improve the quality of evidence for safety surveillance operations.
The public workshop will feature a keynote from Dr. Janet Woodcock, Principal Deputy Commissioner of the FDA. Participants will also hear from Sentinel Initiative leadership on a range of key issues including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic. Additionally, sessions will consider key progress made to fulfill Prescription Drug User Fee Act (PDUFA) commitments, advance innovation within Sentinel, and to expand and extend important capabilities of the data network.
Acknowledgement of Funding
This event is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD006807 totaling $2,975,023 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.