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Bethesda North Marriott Hotel and Conference Center

Feb 28, 2019 7:00 AM - Mar 01, 2019 3:00 PM

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

Advertising and Promotion Regulatory Affairs Conference

Session 7: Current Policy Efforts: Pharma Perspectives on Maintaining Compliance Amidst Dramatic Environmentall Changes

Session Chair(s)

Mark  Gaydos

Mark Gaydos

Former Global Head, Advertising & Promotion, Global Regulatory Affairs

Sanofi, United States

During this session, industry experts will examine the latest and emerging changes in the regulatory environment that are relevant to the promotion of FDA-regulated products. Moreover, attendees will learn about the regulated industry’s policy efforts in this rapidly evolving space. Lastly, the panel will offer insights into ways companies may navigate these changes in order to maintain compliance and avoid enforcement.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify the key environmental changes impacting regulated product promotion
  • Describe the regulated industry’s policy efforts in this space
  • Discuss expert insights regarding risk assessment and ways to maintain compliance in the face of dramatic environmental changes

    Speaker(s)

    Kelly  Goldberg

    Speaker

    Kelly Goldberg

    PhRMA, United States

    Vice President, Law & Senior Counsel for Biopharmaceutical Regulation

    Alexis  Miller, JD

    Speaker

    Alexis Miller, JD

    Merck & Co., Inc., United States

    Acting Global Lead, Global Regulatory Policy and Intelligence

    Mark  Gaydos

    Speaker

    Mark Gaydos

    Sanofi, United States

    Former Global Head, Advertising & Promotion, Global Regulatory Affairs

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