Children & Families
Expanding access to birth control is the surest way to defend women’s right to choose
During the first BASIC meeting, Council members received updates on several ongoing pilot activities including the Observational Medical Outcomes Partnership (OMOP), Mini-Sentinel, the Exploring and Understanding Adverse Drug Reactions (EU-ADR) Project, and the Vaccine Safety Datalink.
Recognizing similarities among these pilot activities, the Council considered potential opportunities for sharing findings and minimizing overlap. Following a presentation by McKinsey & Company on lessons learned from public-private partnerships and complex alliances in other industries, the Council discussed governance of the Sentinel System. Specifically, Council members explored the merits of potential organizational models focusing on governance for multiple users and multiple uses, economic sustainability, and ensuring participation of appropriate stakeholders.
Agenda
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June 2
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Welcome, Introduction, Charge to the Council, and Meeting Objectives
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Remarks from FDA Leadership
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug AdministrationRBRachel Behrman Director, Office of Medical Policy, Center for Drug Evaluation and Research -
Session I: U.S.-Based Medical Product Active Surveillance Pilot Projects
PSPaul Stang Johnson & Johnson and the Observational Medical Outcomes PartnershipJRJudy Racoosin Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and ResearchFCFrancesca Cunningham Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management ServicesTCTrinka Coster Pharmacovigilance Center, United States Army, Office of the Surgeon GeneralRPRichard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute -
Council Discussion
ACArnold Chan OptumInsight Life SciencesMWMyrl Weinberg Chief Executive Officer - National Health Council -
Session II: Other Initiatives That Can Inform Development of the Sentinel System
MSMiriam Sturkenboom Department of Medical Informatics and Epidemiology, Erasmus University Medical CenterCRChesley Richards Office of Prevention through Healthcare, Office of the Director for Policy, Centers for Disease Control and PreventionJSJean Slutsky Center for Outcomes and Evidence, Agency for Healthcare Research and Quality -
Session III: Organization Models for the Sentinel System
NSNavjot Singh MicKinsey & CompanyRMCRobert M. Califf Duke Translational Medicine InstituteAWAlec Walker World Health Information Science Consultants, LLCSBWStanley B. Watson Kaiser Foundation Research Institute -
Discussion Summary and Next Steps
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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