|Project Title||Implementation of Signal Detection Capabilities in the Sentinel System|
Monday, December 3, 2018
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.
Robert J. Margolis, MD, Center for Health Policy at Duke University and the U.S. Food and Drug Administration
- Vaccines, Blood & Biologics
- Devices and Radiologic Health