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Evolving Regulatory Considerations for Medical Affairs Communications
Session Chair(s)
Torrey Cope, JD
Partner
Sidley Austin LLP, United States
This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.
Learning Objective : Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Discuss and assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.
Speaker(s)
Evolving Regulatory Considerations for Medical Affairs Communications
Bill Cook, PHD
AstraZeneca, United States
Senior Global Medical Affairs Leader
Evolving Regulatory Considerations for Medical Affairs Communications
Lisa Hubbard, RPH, RAC
Opus Regulatory, United States
Principal Consultant, Regulatory Advertising and Promotion
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