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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

Head of Labeling and Advertising & Promotion, Global Regulatory Science, Moderna, 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

    Kelly Goldberg

    Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA, United States

    Speaker

    Alexis Reisin Miller, JD

    Alexis Reisin Miller, JD

    Head, Global Regulatory Policy, MSD, United States

    Speaker

    Mark  Gaydos

    Mark Gaydos

    Head of Labeling and Advertising & Promotion, Global Regulatory Science, Moderna, United States

    Speaker

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