2018 Sentinel Initiative Annual Public Workshop


Public Workshop

2018 Sentinel Initiative Annual Public Workshop



Keynote Address

Dr. Scott Gottlieb, Commissioner of Food and Drugs, U.S. Food and Drug Administration


Dr. Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research

Dr. Steven Anderson, Director, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research

Dr. Gregory Pappas, Associate Director for National Device Surveillance, Center for Devices and Radiological Health

Dr. Richard Platt, Principal Investigator of the Sentinel Coordinating Center

This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative. The Food and Drug Administration Amendments Act of 2007 authorized the Sentinel Initiative with the charge of utilizing electronic health care data for post market risk identification and analysis of medical product safety.

The U.S. Food and Drug Administration (FDA) has since continued to refine and expand the Sentinel Initiative’s data infrastructure and capabilities, and in recent years, new analytical tools and enhancements of methods have unlocked access to more diverse sources of data and improved the quality of evidence for safety surveillance activities.

Marking the 10th anniversary of the Sentinel Initiative Public Workshop, the workshop will also feature key leaders from across the Sentinel System stakeholder community including the FDA, Sentinel Data Partners, Sentinel Coordinating Center, regulated industry, and other engaged stakeholders. 

Sessions will be moderated by Dr. Mark McClellan, Director, and Dr. Gregory Daniel, Deputy Director of the Duke-Margolis Center for Health Policy. There will be several opportunities for stakeholder feedback throughout the day. Workshop topics will include:

  • An update on the state of FDA’s Sentinel Initiative
  • Sentinel’s expanding role as a national resource for evidence generation to improve public health and care delivery
  • Opportunities to advance development of Sentinel’s data resources and analytic capabilities

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.