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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
President, Lucy Rose and Associates, United States
Speaker
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA, United States
Speaker
Special Assistant to the Director, Office of Prescription Drug Promotion, CDER, FDA, United States
Speaker
Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas, Bayer Pharmaceuticals, United States
Industry Representative
Vice President, Specialty Compliance, Johnson & Johnson, United States
Speaker
Veterinary Medical Officer, Office of Surveillance and Compliance , CVM, FDA, United States
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