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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 February 5, the Engelberg Center for Health Care Reform at Brookings hosted the seventh annual Sentinel Initiative Public Workshop at the Washington Plaza Hotel in Washington, DC. This event served as a forum for leading experts and stakeholders to discuss the current state of the Mini-Sentinel activities; explore stakeholder perspectives on the future of Sentinel; and identify opportunities to expand its use. Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at FDA, provided the morning keynote address.
Join the conversation at @BrookingsMed or #Sentinel
Stakeholder Perspectives on the Future of the Sentinel System
Strengthening Support for Sentinel's Infrastructure through New Uses
Agenda
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February 5
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Strengthening Support for Sentinel's Infrastructure through New Uses
1:45 pm - 3:00 pm
MDWMarcus D. Wilson President - HealthCoreRLFRachael L. Fleurence Program Director, Comparative Effectiveness Research Methods & Infrastructure - Patient-Centered Outcomes Research InstituteDWDavid Wheadon Senior Vice President and Head of Global Regulatory Affairs, Patient Safety and Quality Assurance - AstraZeneca PharmaceuticalsCVClaudia Vellozzi Chief, Prevention Branch - Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB PreventionCKCChristine K. Cassel President and CEO - National Quality Forum -
Keynote Address
9:15 am - 9:30 am
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
State of Mini-Sentinel Activities
9:30 am - 11:00 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 -
Break
11:00 am - 11:15 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 -
Stakeholder Perspectives on the Future of the Sentinel System
11:15 am - 12:45 pm
KMMKarla M. Miller Assistant VP, Pharmacy Services and Clinical Therapeutics - Hospital Corporation of America, Clinical Services GroupJPDJoseph P. Drozda Director of Outcomes Research - Mercy HealthMWMyrl Weinberg Chief Executive Officer - National Health CouncilSFTSharon F. Terry President and Chief Executive Officer - Genetic AllianceRFRRobert F. Reynolds Vice President and Global Head, Epidemiology in Worldwide Safety - Pfizer, Inc.TMTroy McCall Chief Implementation Officer, Innovation in Medical Evidence Development and Surveillance - Reagan-Udall Foundation for the FDA -
Lunch
12:45 pm - 1:45 pm
KMMKarla M. Miller Assistant VP, Pharmacy Services and Clinical Therapeutics - Hospital Corporation of America, Clinical Services GroupJPDJoseph P. Drozda Director of Outcomes Research - Mercy HealthMWMyrl Weinberg Chief Executive Officer - National Health CouncilSFTSharon F. Terry President and Chief Executive Officer - Genetic AllianceRFRRobert F. Reynolds Vice President and Global Head, Epidemiology in Worldwide Safety - Pfizer, Inc.TMTroy McCall Chief Implementation Officer, Innovation in Medical Evidence Development and Surveillance - Reagan-Udall Foundation for the FDA
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