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Session 2: Insights from the FDA and Industry on Implementation – Policies and Regulations
Session Chair(s)
Twyla Mosey, PharmD
Division Director
FDA, United States
Catherine Gray, PharmD
Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States
This session will provide further FDA insight into policies and regulations and allow for an interactive discussion between FDA and industry on best practices and tools for implementation.
Learning Objective : - Interpret FDA policies and regulations to help develop compliant prescription drug advertising and promotion
- Discuss key takeaways and learnings regarding the future of social media, the CCN Final Rule and compliance activities
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Identify common pitfalls with prescription drug promotion and discuss tools and strategies to address them
Speaker(s)
Speaker
Twyla Mosey, PharmD
FDA, United States
Division Director
Speaker
Lisa Hubbard
Opus Regulatory, Inc., United States
Principal Consultant
Speaker
Josephine Secnik, MBA, MS
Eli Lilly and Company, United States
Executive Director – Product Communications Regulatory Affairs