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This public workshop explored opportunities to implement signal detection capabilities in the Sentinel System. To continue advancing and modernizing this data infrastructure, the FDA is seeking broad stakeholder input on the landscape of methodological approaches for signal detection, as well as the opportunities and challenges to implement these approaches in Sentinel’s distributed data network. Discussion considered key governance and operational needs for implementing signal detection tools in a hypothesis free environment. Stakeholder input received at this workshop will further inform the FDA’s thinking around these priority issues and support strategic planning in the Sentinel System.
Funding for this conference was made possible by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation 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.