FDA Public Workshop on December 3: Implementation of Signal Detection Capabilities in the Sentinel System- Drug Information Update

On December 3, 2018, in cooperative agreement with the U.S. Food and Drug Administration (FDA), the Robert J. Margolis, MD, Center for Health Policy at Duke University will convene a public workshop to explore 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 will also consider 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. 

For more information on this public workshop please visit FDA’s Meetings, Conferences & Workshops (Drugs) page.