This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the U.S. Food and Drug Administration (FDA)’s Sentinel Initiative. With the passage of the Food and Drug Administration Amendments Act of 2007, Congress mandated that FDA develop a national electronic system to track the safety of regulated medical products. In response to this charge, FDA launched the Sentinel Initiative in 2008 with the goal of utilizing electronic health care data for post market risk identification and analysis of medical product safety. Since its inception, Sentinel has continued to refine and expand its data infrastructure and capabilities. In recent years, new analytical tools and enhancements to data methods have unlocked access to more diverse sources of data to improve the quality of evidence for safety surveillance operations.
The public workshop will feature a keynote from Dr. Richard Moscicki, Deputy Center Director for Science Operations, Center for Drug Evaluation and Research. Other key FDA and Sentinel System leadership presenting their perspective on expanding Sentinel’s robust data infrastructure and use include: Dr. Steven Anderson, Director, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research; Dr. Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology; Dr. Gregory Pappas, Associate Director for National Device Surveillance, Center for Devices and Radiological Health; and Dr. Richard Platt, Principal Investigator of the Sentinel Coordinating Center.
Sessions will be moderated by Dr. Mark McClellan, Director of the Duke-Margolis Center for Health Policy, and Dr. Greg Daniel, Deputy Director of the Duke-Margolis Center for Health Policy, who also serves as Principal Investigator for the cooperative agreement between Duke-Margolis and the FDA. There will be several opportunities for stakeholder feedback throughout the day.
Workshop topics will include:
- Opportunities to further integrate and strengthen the Sentinel System within regulatory operations,
- An overview of the current portfolio of Sentinel activities,
- Communication strategies for Sentinel stakeholder engagement, and
- Sentinel’s expanding role as a national resource for evidence generation to improve public health and care delivery.
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.
The webcast for this event will be found on this page and will go live once the event begins.
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