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International Regulatory Advertising and Promotion Considerations
Session Chair(s)
Thomas M. Casola, MBA
Head, Global Regulatory Affairs, Advertising and Promotion, 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 : Discuss how to remain compliant in the international marketing arena.
Speaker(s)
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
Industry Perspective
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