The Food and Drug Administration Amendments Act of 2007 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, FDA launched the Sentinel Initiative in 2008. Mini-Sentinel, a pilot project of the Sentinel Initiative, uses electronic health care data for postmarket risk identification and analysis of medical product safety.
On Wednesday, February 3, 2016 the Center for Health Policy at Brookings will host the eighth annual Sentinel Initiative Public Workshop at the Renaissance Washington, DC Dupont Circle Hotel in Washington, DC. This event will serve as a forum for leading experts and stakeholders to discuss the current state of the Sentinel Initiative. Specific topics will include providing an overview of key activities and uses of the Sentinel System, discussing ongoing and future assessments that could impact regulatory decisions, outlining current and future methods development and tools to support safety assessments, and exploring current activities and stakeholder perspectives on the future of Sentinel including opportunities to modernize and expand its use.
Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, will provide the morning keynote address.
A live webcast of the event will be made available from 9:00 a.m. to 4:00 p.m. on February 3, 2016.
For more information on travel, please click here.
Funding for this conference was made possible in part by a cooperative agreement UFD005197 from Food and Drug Administration, Center for Drug Evaluation Research. The views expressed in written conference materials or publications and by 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.