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International Regulatory Advertising and Promotion Considerations

Regulation of Product Advertising and Marketing in an Ever-changing World

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:

Room Number:



International Regulatory Advertising and Promotion Considerations

Thomas M. Casola, MBA
Vice President, Global Regulatory Affairs, Advertising, Promotion, and Labeling
Shire Specialty Pharmaceuticals, United States

Requirements for disclosure of payments to health care professionals are changing the nature of relationships between pharmaceutical manufacturers and health care practitioners. The impact of the Sunshine Act is already being seen in the US market and new transparency requirements are now being rolled out in International markets. This session will review transparency requirements, what companies should be thinking about to prepare for new disclosure rules in International markets, and how these requirements will affect both commercial and drug development activities.

Learning Objective(s):
Discuss how to remain compliant in the international marketing arena.

Presentation(s) & Speaker(s):
Industry Perspective
Laurent Clerc
Regulatory Affairs Specialist
BMI System Inc., France

Industry Perspective
Jonathon L. Kellerman
Partner, Pharmaceutical and Life Sciences Advisory
PricewaterhouseCoopers LLP, United States

Industry Perspective
Ross Weaver
Executive Director, Global Healthcare Compliance Operations
Amgen, Inc., United States

Industry Perspective
Anthony Brennan
Senior Director, Compliance, HCC
Janssen Pharmaceutical Research & Development, LLC, United States