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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 9: Track B: Strategies to Address Labeling Changes: The Impact on Promotional Materials

Session Chair(s)

Mark  Gaydos

Mark Gaydos

  • Vice President NA General Medicines/US Advertising and Promotion
  • 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)

Mark  Gaydos

The Intersection of Rx Drug Labeling and Promotion

Mark Gaydos

  • Vice President NA General Medicines/US Advertising and Promotion
  • Sanofi, United States
Virginia  Foley

Types of Labeling Changes and Planning Strategies and Implementation, Timing, and Other Considerations

Virginia Foley

  • Principal Consultant
  • Opus Regulatory Inc, United States
Dara S. Katcher Levy, JD

Legal Considerations

Dara S. Katcher Levy, JD

  • Hyman Phelps & McNamara P.C., United States

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