Theme: Regulatory Affairs: The Business of Regulatory Affairs

The conference is intended to provide the Drug, Device, and Biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts.  The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas.  Industry speakers, interactive Q & A, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues.

Conference Chairs:  

Alonza E. Cruse, B.S., District Director -- U.S. Food & Drug Administration, Los Angeles District

Chris Posin, Consultant

Location:  Irvine Marriott - 18000 Von Karman Avenue, Irvine, CA 92612