- February 7, 2018 - November 7, 2017
4:00 AM - 11:00 AM ET
FDA is committed to an open public process that will enable information to be disseminated and stakeholder contributions to be gathered as it explores the scientific, technical, and policy issues that will affect the Sentinel System’s development
10th Annual Sentinel Initiative Public Workshop – Day 1
Wednesday February 7, 2018; 9:00 am to 4:00 pm
Hyatt Regency Bethesda
One Bethesda Metro Center (7400 Wisconsin Avenue)
Bethesda, Maryland 20814
10th Annual Sentinel Initiative Public Workshop – Day 2
Thursday February 8, 2018; 9:00 am to 2:00 pm
U.S. Food and Drug Administration
The Great Room, Building 31, Room 1503B
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
The Food and Drug Administration (FDA) is announcing the following public workshop entitled: "Tenth Annual Sentinel Initiative Public Workshop." The purpose of this two day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance.
Day 1 will be convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA. Key discussion topics will include an update on the state of FDA’s Sentinel Initiative, key safety surveillance activities, and emerging uses of the Sentinel System. In addition, panelists, representing diverse stakeholder perspectives, will provide comments on Sentinel and opportunities to expand its analytic capabilities. This workshop will also provide an opportunity for stakeholder engagement and input on Sentinel’s continued modernization.
Day 2 will be a public workshop sponsored by the FDA targeting researchers who are experienced in using claims data and will build upon the prior public training conducted by FDA on July 10, 2017 (82 FR 19063, April 25, 2017). This second day of the workshop will address more advanced topics, including Sentinel’s inferential analytic capabilities, and methods of identifying unexpected safety concerns. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions.
Attendees are encouraged to review the material FDA presented on July 10, 2017 by visiting the website: https://www.sentinelinitiative.org/communications/sentinel-initiative-events/public-sentinel-training-fda
Further information about the event and registration is available at:
- 10th Annual Sentinel Initiative Public Workshop – Day 1
- 10th Annual Sentinel Initiative Public Workshop – Day 2