June

13
2008

8:30 am EDT - 12:30 pm EDT

Past Event

Forum on Drug Safety and Post-Market Evidence

  • Friday, June 13, 2008

    8:30 am - 12:30 pm EDT

The University Club

1135 16th St, NW
Washington, DC
20036

On June 13, 2008, the Engelberg Center for Health Care Reform hosted a public forum on prescription drug safety and post-market evidence. This public event included a brief overview of current Food and Drug Administration (FDA) activity concerning drug safety; a discussion of a broad-based approach to generating a distributed data network for post-market evidence; and a review of progress to date on a host of technical, legal, and communications-related challenges identified in the course of our ongoing collaborative work in this area.

Mark McClellan, Director of the Engelberg Center for Health Care Reform and Leonard D. Schaeffer Chair in Health Policy Studies at the Brookings Institution, provided introductory remarks and helped moderate this discussion among many of today’s leading health care policy-makers and analysts.

Read full event summary »

Meeting Materials:

Agenda »
Panelists’ Slide Presentations »
Drug Safety Collaboration Legal Guidance Document »
Sentinel Project Handout »
 

Agenda

  • June 13
    • Forum on Drug Safety and Post-Market Evidence

      8:30 am - 12:30 pm

      The Engelberg Center for Health Care Reform hosted a public forum on prescription drug safety that included a brief overview of current Food and Drug Administration activity as well as progress to date on a host of technical, legal and communications-related challenges identified in the course of the center’s ongoing collaborative work in this area.

      Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
      AvE
      Andrew von Eschenbach Commissioner, FDA
      JW
      Janet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration
      MB
      Marc Boutin
      AC
      Arnold Chan OptumInsight Life Sciences
      GH
      Gigi Hirsch Executive Director, MIT Center for Biomedical Innovation
      JK
      Judy Kramer Executive Director of the Clinical Trials Transformation Initiative, Duke University
      SL
      Sharon Levine Associate Executive Medical Director, Kaiser Permanente
      JM
      Janet Marchibroda Chair, Health Information Technology Initiative
      GN
      Garry Neil Johnson & Johnson
      RP
      Rich Platt Harvard Medical School and Harvard Pilgrim Health Care Institute
      KBR
      Kristen B. Rosati Coppersmith Schermer & Brockelman PLC
      LR
      Lee Rucker AARP Public Policy Institute, AARP
      MDW
      Marcus D. Wilson President - HealthCore
      Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
      AvE
      Andrew von Eschenbach Commissioner, FDA
      JW
      Janet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration
      MB
      Marc Boutin
      AC
      Arnold Chan OptumInsight Life Sciences
      GH
      Gigi Hirsch Executive Director, MIT Center for Biomedical Innovation
      JK
      Judy Kramer Executive Director of the Clinical Trials Transformation Initiative, Duke University
      SL
      Sharon Levine Associate Executive Medical Director, Kaiser Permanente
      JM
      Janet Marchibroda Chair, Health Information Technology Initiative
      GN
      Garry Neil Johnson & Johnson
      RP
      Rich Platt Harvard Medical School and Harvard Pilgrim Health Care Institute
      KBR
      Kristen B. Rosati Coppersmith Schermer & Brockelman PLC
      LR
      Lee Rucker AARP Public Policy Institute, AARP
      MDW
      Marcus D. Wilson President - HealthCore