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Session 4B: Beginning with the End in Mind: Early Cross-Functional Planning for Promotion
Session Chair(s)
Alyson Andrikanich, PHARMD
Senior Director, Advertising and Promotion, Regulatory Affairs Americas, Bayer, United States
Anthony Genovese, PHARMD
Group Leader, Regulatory Advertising and Promotion, Johnson & Johnson, United States
Regulatory Advertising and Promotion has a critical role in early-stage cross-functional development discussions. Deciding on clinical study design and endpoints has significant implications for advertising and promotion once the product is launched. In addition, FDA’s Consistent with FDA Labeling Guidance plays a role in these early cross-functional planning discussions.
Learning Objective :
- Identify how early development decisions impact advertising and promotion
- Describe regulatory advertising and promotion’s role and value in early cross-functional planning
- Illustrate how the FDA’s Consistent with FDA Labeling Guidance can influence decisions on clinical trial design
Speaker(s)
Denise Sanchez, JD, MA, MS
Principal Consultant, Opus Regulatory, United States
Target Product Profiles and Drug and Device Development
Kristen Heinlein, PHARMD
Vice President, Advertising & Promotion Regulatory, Takeda, United States
Effectively Presenting CFL Information in Promotional Communications
Alyson Andrikanich, PHARMD
Senior Director, Advertising and Promotion, Regulatory Affairs Americas, Bayer, United States
Beginning with the End in Mind: Hypothetical Case Study
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