Presentations
Implications of Global Regulatory Changes for Medical Device Manufacturers
8:30-9:30 am | Gold Room, Lobby Level
Presented by:
Paul C. Brooks, BSI PS Healthcare
Michael B. Gropp, Medtronic Inc.
Postapproval Considerations for Drugs and Biologics
8:30-9:30 am | Terrace Room, Terrace Level
Presented by:
Douglas M. Hunt, Baxter Healthcare
Shamim Ruff, Amgen Inc.
Making Sense of EU Vigilance Reporting Requirements
10:00-11:00 am | Crystal Room, Lobby Level
Presented by:
Jaap L. Laufer, Emergo Group Inc.
Special Challenges With Postapproval Combination Products
10:00-11:00 am | French Room, Lobby Level
Presented by:
Giuliana G. Bernacca, Sorin Biomedica Cardio Srl
Monitoring the Practice of Medicine and Off- Label Uses
10:00-11:00 am | Terrace Room, Terrace Level
Presented by:
Patrick Bilbo, Organogenesis Inc.
James R. Ravitz, Arent Fox LLP
Jeffrey Dow, Synthes USA
Dealing With Follow-On Biologics Issues
10:00-11:00 am | Gold Room, Lobby Level
Presented by:
Erika Lietzan, Covington & Burling LLP
Elaine H. Tseng, King & Spalding
Crisis Management and the Regulatory Professional
11:00 am-12:00 pm | Gold Room, Lobby Level
Presented by:
Robert J. Bard, Health Care Technologies Consultants
Michael A. Swit, The Weinberg Group Inc.