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Session 7: Current Policy Efforts: Pharma Perspectives on Maintaining Compliance Amidst Dramatic Environmentall Changes
Session Chair(s)
Mark Gaydos
Head of Labeling and Advertising & Promotion, Global Regulatory Science
Moderna, United States
During this session, industry experts will examine the latest and emerging changes in the regulatory environment that are relevant to the promotion of FDA-regulated products. Moreover, attendees will learn about the regulated industry’s policy efforts in this rapidly evolving space. Lastly, the panel will offer insights into ways companies may navigate these changes in order to maintain compliance and avoid enforcement.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify the key environmental changes impacting regulated product promotion
- Describe the regulated industry’s policy efforts in this space
- Discuss expert insights regarding risk assessment and ways to maintain compliance in the face of dramatic environmental changes
Speaker(s)
Speaker
Kelly Goldberg
PhRMA, United States
Vice President, Law & Senior Counsel for Biopharmaceutical Regulation
Speaker
Alexis Reisin Miller, JD
Merck & Co., Inc., United States
Head, Global Regulatory Policy
Speaker
Mark Gaydos
Moderna, United States
Head of Labeling and Advertising & Promotion, Global Regulatory Science