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Bethesda North Marriott Hotel and Conference Center

Feb 28, 2019 7:00 AM - Mar 01, 2019 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 4: Industry Implementation of the Consistency with Labeling Guidance

Session Chair(s)

Glenn N. Byrd, MBA

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

Speaker

Glenn N. Byrd, MBA

GByrd Ad-Promo Solutions, LLC, United States

President

Tara  Barbanell

Speaker

Tara Barbanell

Amgen, Inc., United States

Director, Regulatory Promotion & Material Compliance

Michael A. Sauers, RAC

Speaker

Michael A. Sauers, RAC

Eli Lilly and Company , United States

Director, Global Regulatory Affairs - Advertising and Promotion

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