Thirteenth Annual Sentinel Initiative Public Workshop


Public Workshop

Thirteenth Annual Sentinel Initiative Public Workshop

November 8, 2021 10:00AM - November 9, 2021 2:00PM

Virtual Workshop

Day 1: Thirteenth Annual Sentinel Initiative Public Workshop

Day 2: Thirteenth Annual Sentinel Initiative Public Workshop

Meetings Dates and Times

Monday, November 8,  2021: 10:00am - 2:00pm

Tuesday, November 9,  2021: 10:00am - 2:00pm



The Sentinel Initiative was launched in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is comprised of several components including the Sentinel System, the Active Risk Identification and Analysis System, the Biologics Effectiveness and Safety Initiative, and FDA Catalyst. The Food and Drug Administration (FDA) is committed to facilitating stakeholder engagement on approaches to modernize the Sentinel Initiative’s capabilities. 

The annual public workshop is a gathering of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative, provide training on the Sentinel System’s tools and data infrastructure, and promote engagement and collaboration with patients, industry, academia, and consumers. The 13th Annual Sentinel Initiative Public Workshop will convene on November 8-9, 2021, and is hosted by the Duke-Margolis Center for Health Policy under a cooperative agreement with the FDA. The workshop will be held as a virtual webinar 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.

This year’s meeting will feature a keynote by FDA’s Dr. Patrizia Cavazzoni, as well as presentations from numerous expert panelists who will provide updates on key Sentinel Initiative developments, milestones, and strategic aims. The discussion will also consider recent activities and applications of the Sentinel Initiative as part of the U.S. FDA’s efforts to protect and promote public health during the COVID-19 pandemic.


A draft agenda has been posted to this site. Additional meeting materials will be posted on this event page as they become available.



Please register, using the link above, for access to the virtual workshop. Registrants will be encouraged to submit questions during the meeting, and meeting moderators will work them into the Q&A discussion.

If you have any questions or concerns, please email


Acknowledgement of Federal Support

Funding for this event was made possible, in part, by the Food and Drug Administration through grant U01FD006807. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.