Details
On Tuesday, January 14, 2014, the Engelberg Center for Health Care Reform at Brookings hosted the sixth annual Sentinel Initiative Public Workshop at the Marriott at Metro Center in Washington, DC. This annual workshop brings together leading experts and interested stakeholders for a productive exchange on the 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. Mini-Sentinel, a pilot project of the Sentinel Initiative, utilizes electronic health care data for postmarket risk identification and analysis of medical product safety. The development of the Mini-Sentinel pilot marks an important expansion of FDA’s surveillance capabilities, with the potential for delivering more rapid and actionable information to inform regulators, health care professionals, and patients.
This event also served as a forum for participants to discuss the use of Sentinel as a national resource to support evidence generation and a learning health care system. Specific topics that were addressed include:
An overview of the state of the Mini-Sentinel pilot program;
Next steps for the Sentinel Initiative;
Sentinel as a critical component of the emerging national health infrastructure; and
Stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety.
Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, provided the morning keynote address.
This workshop was hosted by the Engelberg Center for Health Care Reform at Brookings. Further event information and materials are available here.
Additional Information
Contributors
Janet Woodcock MD, MPH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Richard Platt MD, MSc; Department on Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA
Bruce Fireman MA; Kaiser Permanente Division of Research, Oakland, CA;
Katherine Yih PhD, MPH; Department on Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA
Marsha Reichman PhD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Thomas Gross MD; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD
Michael Nguyen MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Rachel Sherman MD, MPH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Azadeh Shoaibi MS, MHS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Karen Midthun MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
William Maisel MD, MPH; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD
Jeff Brown PhD; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA
Lesley Curtis PhD; Duke Clinical Research Institute and Duke University School of Medicine, Durham, NC
Elizabeth Chrischilles PhD, MS; College of Public Health, University of Iowa, Iowa City, IA
Robert Califf MD; Duke University School of Medicine, Durham, NC
Joe Selby MD, MPH; Patient Centered Outcomes Research Institute, Washington, DC
Michael Rosenblatt MD; Merck & Co. Inc.
Sally Greenberg JD; National Consumers League, Washington, DC
Kimberly McCleary BA; FasterCures, Washington, DC