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Session 10: Track A: Promotional Review of Medical Developed Communications
Session Chair(s)
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
Traditionally, the role of the advertising and promotional regulatory affairs professional has focused on providing regulatory expertise to the Promotional Review Committee; this is especially true in larger organizations. However, the scope of responsibilities of regulatory affairs professionals, particularly in smaller organizations, has expanded to include providing regulatory expertise to the Medical Review Committee (MRC) via regulatory review of medical information/communications content. This session will focus on this aspect of regulatory review and will include a general overview of medical information/medical affairs and the evolution of medical content, as well as provide best practices for the regulatory review of medical content.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify the role and purpose of Medical Affairs and the Medical Review Committee
- Describe the role of the regulatory professional on the MRC and discuss approaches for effective cross-functional collaboration
- Discuss regulatory contributions to the MRC that enable and enhance successful medical content reviews
Speaker(s)
Speaker
Nicole A Lare, MBA
Celgene, United States
Associate Director
Speaker
Hadley H Le, PharmD
Neurocrine Biosciences, Inc., United States
Associate Director, Medical Affairs
Speaker
Eileen Valenta, MBA
Valenta Consulting , United States
President
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