May 7

Past Event

Roundtable on Active Medical Product Surveillance: Learning from The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project

Event Materials

Audio

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Summary

On May 7, the Engelberg Center for Health Care Reform hosted the roundtable webinar, "The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project."

Download presentation slides » (pdf)

Discussion featured presentations from Dr. Thomas P. Gross, Deputy Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (CDRH), Food and Drug Association (FDA), and Dr. Fredric S. Resnic, Medical Director, Cardiac Catheterization Laboratory, Brigham and Women’s Hospital. Panelists focused on the ongoing post-market surveillance work being done at CDRH and the Massachusetts interventional cardiology device safety surveillance pilot project using the Web-based DELTA (data extraction and longitudinal time analysis) system for identifying low frequency safety signals.

Details

May 7, 2010

12:00 PM - 1:00 PM EDT

The Brookings Institution

Live Webinar

1775 Massachusetts Ave., NW

Map

For More Information

Engelberg Center for Health Care Reform

(202) 797-4391

Event Agenda

  • Welcome and Introduction

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

  • Update on CDRH Post-Market Surveillance Work

    • Thomas Gross

      Deputy Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration

  • The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project

    • Frederic S. Resnic

      Medical Director, Cardiac Catheterization Laboratory, Brigham and Women's Hospital