Perspective on Regulations from an Insider and a Patient to Close the 2009 PDA/FDA Joint Regulatory Conference

Bethesda, Md.  Something unique to the long-running PDA/FDA Joint Regulatory Conference will occur this year. Not only will the meeting delve deeply into the most pressing regulatory issues of the day, but its closing day will include a powerful reality check when regulatory affairs professional and breast cancer survivor Amy Giertych provides her unique perspective as both an insider and a patient.

The senior director of Baxter’s Global RA will discuss her experience as a patient, a professional and a consumer of the life-saving medicines the industry manufactures.

The closing sessions of the 2009 PDA/FDA Joint Regulatory Meeting also will focus on the U.S. FDA’s future compliance expectations. The final session will provide the perfect point of departure for attendees, as officials within the FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Veterinary Medicine (CVM) will provide brief updates about current initiatives within their areas of expertise and will participate in a closing panel discussion.

The following Agency members have been invited to speak at this session:
Deborah Autor, Director, Office of Compliance (CDER)
Mary Malarkey, Director, Office of Compliance and Biologic Quality (CBER)
Timothy Ulatowski, Director, Office of Compliance (CDRH)
Daniel McChesney, Director, Office of Surveillance and Compliance (CVM)
Steven Silverman, Assistant Director, Office of Compliance (CDER) Joeseph Famulare, Deputy Director, Office of Compliance (CDER)Richard Friedman, Director, Division of Manufacturing and Product Quality (CDER)

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