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 convened on November 8-9, 2021, and was hosted by the Duke-Margolis Center for Health Policy under a cooperative agreement with the FDA. The workshop was held as a 2-day virtual webinar from 10:00am – 2:00pm each day, and provided an opportunity for attendees to discuss recent achievements and developments as well as engage with the broader community of patients, consumers, and scientific stakeholders.
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Funding for this conference was made possible by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation and Research. The views expressed in written conference materials and the speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services, nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.
Further event information and materials are available here.