Sixteenth Annual Sentinel Initiative Public Workshop скачать в хорошем качестве

Sixteenth Annual Sentinel Initiative Public Workshop

On November 7, 2024, the Duke-Margolis Institute for Health Policy hosted the 16th Annual Sentinel Initiative Public Workshop under a cooperative agreement with the United States Food and Drug Administration (FDA). 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 public workshop featured a keynote from Patrizia Cavazzoni, Director of the FDA's Center for Drug Evaluation and Research. Participants also heard from Sentinel Initiative leadership on a range of key issues illustrated by exemplary use cases. Sessions considered key progress made in--and upcoming opportunities for--the Sentinel System, BEST System, and the landscape of community engagement.