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#342: Evolving Regulatory Considerations for Medical Affairs Communications
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-642-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Torrey Cope, JD

Speaker

Evolving Regulatory Considerations for Medical Affairs Communications
Bill Cook

Evolving Regulatory Considerations for Medical Affairs Communications
Lisa Hubbard, RPh, RAC


Speakers
BC

Bill Cook

Senior Global Medical Affairs Leader, AstraZeneca, United States
avatar for Torrey Cope

Torrey Cope

Partner, Sidley Austin LLP, United States
Torrey Cope advises and represents clients in a full range of regulatory, enforcement, litigation, and transactional matters involving FDA issues. He has been recognized as a “Life Sciences Star” in the FDA: Pharmaceutical category by LMG Life Sciences since 2016 and has been... Read More →
avatar for Lisa Hubbard

Lisa Hubbard

Principal Consultant, Regulatory Advertising and Promotion, Opus Regulatory, Inc., United States
Lisa Hubbard is a Principal Consultant in Advertising and Promotion at Opus Regulatory, Inc. Her prior roles included Director, Advertising and Promotional Compliance at Alexion/Astra Zeneca and Senior Regulatory and Medical Consultant at One Source Regulatory. Lisa spent 15 years... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   04: MedAffairs-SciComm, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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