Jan 1

Live Event

Brookings Active Surveillance Implementation Council Meeting #3

Event Materials

Summary

On June 1, the Engelberg Center hosted the third Brookings Active Surveillance Implementation Council meeting, with Council members gathering to discuss the role of medical product developers in active medical product surveillance and specifically their role in improving methods.

Discussion focused on medical product developer's perspectives, including what role developers want to play in active surveillance and possible approaches for achieving such roles. In addition, participants discussed the role OMOP, Mini-Sentinel, and other federal initiatives have played in addressing developer concerns around methods for active surveillance, as well as types of organizational models that could support a long-term strategy for methods research and development.

Details

January 1, 0001

12:00 AM - 12:00 AM EST

The Brookings Institution

Saul/Zilkha Rooms

1775 Massachusetts Avenue, NW

Map

For More Information

Engelberg Center for Health Care Reform

(202) 797-4391

Event Agenda

  • Welcome, Introduction, and Meeting Objectives

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

  • Remarks from the Office of the Commissioner

    • John Taylor III

      Office of the Commissioner

      U.S. Food and Drug Administration

  • Current Status of and Future Challenges in Active Surveillance

    • Janet Woodcock

      Center for Drug Evalution and Research

      U.S. Food and Drug Administration

    • Rachel Sherman

      Center for Drug Evaluation and Research

      U.S. Food and Drug Administration

    • Donald O. Beers

      Office of Chief Counsel

      U.S. Food and Drug Administration

  • Brief Overview of Mini-Sentinel

    • Richard Platt

      Harvard Medical School

      Harvard Pilgrim Health Care Institute

  • Brief Overview of the Observational Medical Outcomes Partnership

    • Paul Stang

      Johnson & Johnson

      Observational Medical Outcomes Partnership

  • Medical Product Developer's Perspectives in Post-Market Medical Product Surveillance

    • Michael Rosenblatt

      Merck & Co., Inc.

    • Howard Hutchinson

      AstraZeneca

    • Briggs Morrison

      Pfizer

    • Richard Kuntz

      Medtronic, Inc.

  • Moderated Discussion

    • Myrl Weinberg

      National Health Council

    • Stanley B. Watson

      Kaiser Foundation Research Institute

    • Gregory W. Daniel

      HealthCore

    • Robert M. Califf

      Duke Translational Medicine Institute

      Duke University Medical Center

  • Medical Product Developer Roles in Improving Methods for Post-Market Medical Product Surveillance

    • Ronald Lee Krall

      University of Pennsylvania Center for Bioethics

    • Elliott M. Levy

      Bristol-Myers Squibb

    • Alexander M. Walker

      World Health Information Science Consultants, LLC

      Harvard School of Public Health

    • Garry Neil

      Corporate Office of Science and Technology

      Johnson & Johnson

  • Closing Remarks

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies