On February 2, 2017, the Duke-Margolis Center for Health Policy will host the Ninth Annual Sentinel Initiative Public Workshop at the Barbara Jordan Conference Center at the Kaiser Family Foundation. This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative. With the passage of the Food and Drug Administration Amendments Act of 2007, Congress mandated that the U.S. Food and Drug Administration (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 workshop will feature a keynote from Dr. Janet Woodcock, Director of the 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. Peter Marks, Director of the 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. There will be several opportunities for stakeholder feedback throughout the day. Workshop topics will include:
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.
Registration for this event is open. Please note that in person registration is limited and first come, first serve. This event will also be webcast. Please find us at healthpolicy.duke.edu for more information.
Thursday, February 2, 2017 8:30 AM - 4:30 PMEastern Time
Kaiser Family Foundation Barbara Jordan Conference1330 G St NWBarbara Jordan Conference CenterWashington, District of Columbia 20005USA
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