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Session 4: Industry Implementation of the Consistency with Labeling Guidance
Session Chair(s)
Glenn N. Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC, United States
With the finalization of the FDA Consistency with Labeling guidance in 2018, industry has been working to implement these principles in their external communications and promotional activities. Join this industry panel discussion to learn more about the opportunities and challenges this guidance affords industry and view some real-world examples to illustrate the principles of this guidance.
Learning Objective : At the conclusion of this session, participants should be able to:Describe the underlying principles of the Consistency with Labeling guidance- Assess and apply those principles to effect real change in how to communicate/promote under this framework
- Describe the holistic research agenda of FDA/OPDP
- Identify individual topic areas and how they fit together
- Review results of recent research
Speaker(s)
Glenn N. Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC, United States
Speaker
Tara Barbanell
Director, Regulatory Promotion & Material Compliance, Amgen, Inc., United States
Speaker
Michael Sauers, RAC
Director, Global Regulatory Affairs - Advertising and Promotion, Eli Lilly and Company , United States
Speaker
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