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Bethesda North Marriott Hotel and Conference Center

2019 年 02 月 28 日 7:00 上午 - 2019 年 03 月 01 日 3:00 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 10: Track A: Promotional Review of Medical Developed Communications

Session Chair(s)

Micheline  Awad, MBA

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)

    Nicole A Lare, MBA

    Speaker

    Nicole A Lare, MBA

    Celgene, United States

    Associate Director

    Hadley H Le, PharmD

    Speaker

    Hadley H Le, PharmD

    Neurocrine Biosciences, Inc., United States

    Associate Director, Medical Affairs

    Eileen  Valenta, MBA

    Speaker

    Eileen Valenta, MBA

    Valenta Consulting , United States

    President

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