Series: Brookings Active Surveillance Implementation Council | Number 2 of 4 « Previous | Next »

Jun 2

Past Event

Brookings Active Surveillance Implementation Council Meeting #1

Event Materials

Summary

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.

Event Agenda

  • Welcome, Introduction, Charge to the Council, and Meeting Objectives

  • Remarks from FDA Leadership

    • Janet Woodcock

      Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • Rachel Behrman

      Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  • Session I: U.S.-Based Medical Product Active Surveillance Pilot Projects

    • Paul Stang

      Johnson & Johnson, Foundation for the National Institutes of Health's Observational Medical Outcomes Partnership

    • Judy Racoosin

      Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    • Francesca Cunningham

      Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management Services

    • Trinka Coster

      Pharmacovigilance Center, United States Army, Office of the Surgeon General

    • Richard Platt

      Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute

  • Council Discussion

    • Briggs Morrison

      Primary Care Medicines Development Group, Pfizer, Inc.

    • Arnold Chan

      i3 Drug Safety

    • Myrl Weinberg

      National Health Council

  • Session II: Other Initiatives That Can Inform Development of the Sentinel System

    • Miriam Sturkenboom

      Department of Medical Informatics and Epidemiology, Erasmus University Medical Center

    • Chesley Richards

      Office of Prevention through Healthcare, Office of the Director for Policy, Centers for Disease Control and Prevention

    • Jean Slutsky

      Center for Outcomes and Evidence, Agency for Healthcare Research and Quality

    • Claudia Williams

      Office of the National Coordinator for Health Information Technology

  • Session III: Organization Models for the Sentinel System

    • Navjot Singh

      MicKinsey & Company

    • Robert Califf

      Duke Translational Medicine Institute, Division of Cardiology at Duke University Medical Center

    • Alec Walker

      World Health Information Science Consultants

    • Stanley Watson

      Kaiser Foundation Research Institute

  • Discussion Summary and Next Steps

Details

June 2, 2010

8:30 AM - 3:30 PM EDT

The Brookings Institution

Stein Room

1775 Massachusetts Avenue, N.W.

Map

More from Brookings

SERIES: Brookings Active Surveillance Implementation Council | Number 2