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Session 12: Building Bridges: Creating and Maintaining a Productive Relationship with FDA on Advertising and Promotion Issues
Session Chair(s)
Lucy Rose, MBA
President
Lucy Rose and Associates, United States
For US regulatory affairs professionals, the FDA is a key customer and establishing an effective, productive relationship with the agency cannot be left to chance. A solid foundation for this relationship is a keen understanding of the role and objectives of the FDA on advertising and promotion issues. With that knowledge, company regulatory professionals can begin to build and then sustain a strategic, mutually respectful relationship with FDA that can result in greater efficiency and transparency, more effective promotional materials, and fewer surprises.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe examples of best practices of effective communications with OPDP and APLB
- Identify appropriate needs and opportunities to proactively interact with OPDP and APLB
- Discuss the various roles and responsibilities within OPDP and APLB to enhance appropriate interactions and touch points
Speaker(s)
Panelists
Jean-Ah Kang, PharmD
FDA, United States
Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
Panelists
Dolores Shank-Samiec, MS
Merck, United States
Retiring as of 3/5/2021
Panelist
Michele Sharp, PharmD
Eli Lilly and Company, United States
Senior Director, Global Regulatory Affairs
Panelists
Lisa Stockbridge, PhD
FDA, United States
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
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