|Project Title||Sentinel Initiative Public Workshop - Ninth Annual|
Wednesday, February 1, 2017
The Ninth Annual Sentinel Initiative Public Workshop was held on Thursday, February 2, 2017. Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this one-day workshop brought the stakeholder community together to discuss a variety of topics on active medical product surveillance.
Topics included an update on the state of FDA’s Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and accomplishments of the Sentinel System from 2016. In addition, panelists discussed the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities.
Mark McClellan, MD, PhD, Duke-Robert J. Margolis Center for Health Policy and Robert J. Margolis Professor of Business, Medicine and Health Policy, Duke University
Richard Moscicki, MD, Deputy Center Director for Science Operations, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Steven Anderson, PhD, MPP, Director, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration; Gerald J. Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Gregory Pappas, MD, PhD, Associate Director for National Device Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Richard Platt, MD, MSc, Professor and Chair, Department of Population Medicine, Harvard Medical School, Executive Director, Harvard Pilgrim Health Care Institute, and Principal Investigator, Sentinel Coordinating Center