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Session 9: Track B: Strategies to Address Labeling Changes: The Impact on Promotional Materials
Session Chair(s)
Mark Gaydos
Global Head, Advertising & Promotion, Global Regulatory Affairs
Sanofi, United States
This session will focus on the impact of prescription drug and biologic labeling changes on product promotion. Specifically, the panel will consider the timing associated with ensuring promotional materials reflect, and are accompanied by, current prescribing information or, for advertising, a brief summary of prescribing information. Criteria and timelines for updating important risk/safety information related to labeling changes will also be addressed.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Articulate the types of labeling changes and their impact on advertising and promotion
- Identify internal functions and processes involved in assessing labeling updates and implementing them in promotion
- Understand the importance of timely implementation of labeling changes in promotion and provision of updated prescribing information
Speaker(s)
The Intersection of Rx Drug Labeling and Promotion
Mark Gaydos
Sanofi, United States
Global Head, Advertising & Promotion, Global Regulatory Affairs
Types of Labeling Changes and Planning Strategies and Implementation, Timing, and Other Considerations
Virginia Foley
Constellation, United States
VP Regulatory Lead, Life Sciences & Healthcare
Legal Considerations
Dara S. Katcher Levy, JD
Hyman Phelps & McNamara P.C., United States
Director
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