Health Care Policy
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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.
Sentinel Initiative Public Workshop Part 1
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Sentinel Initiative Public Workshop Part 2
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Sentinel Initiative Public Workshop Part 3
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Sentinel Initiative Public Workshop Part 4
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Sentinel Initiative Public Workshop Part 5
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Agenda
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January 14
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The Sentinel Initiative: The Next Steps
9:15 am
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
State of Mini-Sentinel Activities
9:35 am
RPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstituteMERMarsha E. Reichman Senior Advisor and Scientific Lead for Surveillance Programs - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug AdministraionMDNMichael D. Nguyen Deputy Director, Division of Epidemiology, Office of Biostatistics and Epidemiology - Center for Biologics Evaluation and Research, US Food and Drug Administration -
Overview of Enhancements Underway to Mini-Sentinel
11:00 am
LHCLesley Huntley Curtis Associate Professor in Medicine - Duke University School of Medicine -
Emerging National Health Information Infrastructure
1:00 pm
RMCRobert M. Califf Duke Translational Medicine InstituteRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute -
Break
10:50 am
RMCRobert M. Califf Duke Translational Medicine InstituteRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute -
Lunch
12:00 pm
RMCRobert M. Califf Duke Translational Medicine InstituteRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute -
Break
2:30 pm
RMCRobert M. Califf Duke Translational Medicine InstituteRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute -
Stakeholder Feedback on Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action
2:45 pm
RSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLC
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