Advamed2009 diskutiert Register - Veranstaltungshinweis

Regulatory
The Value and Challenges of Device Registries
Tuesday, October 13, 2009 ~ 09:00 AM – 10:15 AM
Panel Location: 207B
There is growing interest in the post-market data provided by registries. FDA’s sentinel initiative
program and AHRQ’s comparative effectiveness and Effective Health Care (EHC) programs are
developing stand alone device registries, networked registries, and other initiatives to monitor
post-market device safety and to improve quality and patient outcomes. High-level FDA and AHRQ
representatives will discuss the value and challenges associated with registries. A representative
will discuss an existing and active device registry. Demetrios Kouzoukas, former Principal Associate
Deputy Secretary of HHS and currently Of Counsel at Covington & Burling, will moderate the panel.
Chair:
Demetrios Kouzoukas, Of Counsel, Covington & Burling
Panelists:
Elise Berliner, PhD, Director, Technology Assessment Program, Center for Outcomes and Evidence,
Agency for Healthcare Research and Quality
Thomas P. Gross, MD, Deputy Director, Office of Surveillance and Biometrics, FDA
Donald A. Middlebrook, Vice President, Corporate Quality and Regulatory Affairs, Thoratec Corporation