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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 Pharmaceuticals, 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)
Target Product Profiles and Drug and Device Development
Denise Sanchez, JD, MA, MS
Opus Regulatory Inc., United States
Principal Consultant
Effectively Presenting CFL Information in Promotional Communications
Kristen Heinlein, PharmD
Takeda, United States
Vice President, Advertising & Promotion Regulatory
Beginning with the End in Mind: Hypothetical Case Study
Alyson Andrikanich, PharmD
Bayer Pharmaceuticals, United States
Senior Director, Advertising and Promotion, Regulatory Affairs Americas