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Session 11 Track B: 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 : Upon completion 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
- Understand the various roles and responsibilities within OPDP and APLB to enhance appropriate interactions and touch points
Speaker(s)
Panelist
Jean-Ah Kang, PharmD
FDA, United States
Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
Panelist
Leah Palmer, PharmD
United States
Consultant, Regulatory Promotion
Panelist
Sheetal Patel, PharmD
Johnson & Johnson, United States
Vice President, Specialty Compliance
Panelist
Lisa Stockbridge, PhD
FDA, United States
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER