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Session 10B: The Evolving World of Scientific Exchange
Session Chair(s)
Lynn Bowen, PhD
Vice President, Regulatory Affairs Advertising Promotion & Labeling
Alkermes, Inc., United States
The numerous and varied opportunities for scientific exchange (reactive and proactive) continue to introduce new challenges. This session aims to provide a regulatory background for these types of communications and discuss different examples of scientific exchange that various companies are currently participating in today, for example, medical booth activities, medical affairs activities, non-CME sponsored symposia, and more.
Learning Objective :
- Describe the regulatory basis for scientific exchange
- Evaluate different features of scientific exchange
- Identify the different considerations in review of proactive scientific exchange
Speaker(s)
Scientific Exchange Mock Scenarios and Discussion
Lynn Bowen, PhD
Alkermes, Inc., United States
Vice President, Regulatory Affairs Advertising Promotion & Labeling
Legal and Regulatory Framework for Scientific Exchange
Heather Banuelos, JD
King & Spalding LLP, United States
Counsel
Proactive Medical Affairs Communications
Janet Gottlieb, PhD
Canopy Life Sciences, United States
Head of Medical Review Solutions