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Session 3: Pro Tip! Effective Engagement between FDA’s OPDP/APLB/CVM and Industry Leaders
Session Chair(s)
Fadwa Almanakly, PharmD
Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas
Bayer Pharmaceuticals, United States
Sheetal Patel, PharmD
Vice President, Specialty Compliance
Johnson & Johnson, United States
For US regulatory affairs professionals, understanding of the role and objectives of the FDA on advertising and promotion issues is the foundation for establishing an effective, productive relationship with FDA. During this session, you will gain insights from both FDA and regulatory industry representatives to identify approaches to effectively interact with the FDA and begin to build and sustain a strategic, successful working relationship with FDA.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the role and objectives of the FDA on advertising and promotion issues
- Demonstrate how to build and then sustain a strategic, mutually respectful relationship with FDA
- Develop and establish an effective, productive relationship with the agency
Speaker(s)
Moderator
Lucy Rose, MBA
Lucy Rose and Associates, United States
President
Speaker
Lisa Stockbridge, PhD
FDA, United States
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
Speaker
Jean-Ah Kang, PharmD
FDA, United States
Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
Speaker
Fadwa Almanakly, PharmD
Bayer Pharmaceuticals, United States
Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas
Industry Representative
Sheetal Patel, PharmD
Johnson & Johnson, United States
Vice President, Specialty Compliance
Speaker
Kathryn Dennehy, DVM
FDA, United States
Veterinary Medical Officer, Office of Surveillance and Compliance , CVM
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