Pharmaceutical & Drug Policy
Incorporating information on therapeutic alternatives into the IRA prescription drug negotiations
An expert technical workshop was convened to discuss distributed data networks and their use in active medical product surveillance.
This one-day technical workshop identified key features of existing data networks conducting medical product safety surveillance; discussed data infrastructure needs for a future national active surveillance system; and discussed barriers and explored solutions to private data environment participation in active surveillance. The overarching goal of the meeting was to stimulate productive discussion and exchange of ideas on these topics.
Convened by the Engelberg Center for Health Care Reform at Brookings and supported by a grant from the Food and Drug Administration.
Agenda
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November 23
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Welcome, Introduction and Meeting Objectives
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
FDA Perspective on Distributed Networks for Active Surveillance
JRJudy Racoosin Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research -
Experience with HMO Research Network
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Experience with Vaccine Safety Datalink
JBJames Baggs Immunization Safety Office, National Center for Preparedness, Detection, and Control of Infectious Diseases, CDC -
Experience with DARTNet
WPWilson Pace Professor of Family Medicine, University of Colorado Health Sciences Center -
Experience with EU-ADR
MSMiriam Sturkenboom Department of Medical Informatics and Epidemiology, Erasmus University Medical Center -
Experience with Observational Medical Outcomes Partnership
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Response Panel: What Data Infrastructure Will Achieve the Needs for Active Surveillance in the Near and Longer Terms?
EAElizabeth Andrews Vice President of Pharmacoepidemiology and Risk Management, RTI Health SolutionsVKVik Kheterpal President and Chief Executive Officer, CareEvolution -
Panel II: Barriers and Solutions to Private Sector Participation in Active Surveillance Networks
MDMary Durham Senior Investigator, Director, Center for Health Research, Vice President for Research, Kaiser Foundation HospitalsJPJonathan Perlin President, Clinical Services and Chief Medical Officer, Hospital Corporation of AmericaTMTerri Madison President, i3 Drug SafetyJWJanet Wright Senior Vice President for Science and Quality, American College of CardiologyMDWMarcus D. Wilson President - HealthCore -
Recap and Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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