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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

AdPromo: Assessing Risk in the Current Regulatory Environment

    Session Chair(s)
      Mark  Gaydos

      Mark Gaydos

      • VP, NA General Medicines/US Advertising and Promotion, Global Regulatory Affairs
      • Sanofi, United States
    The interpretation and application of advertising and promotion regulations continue to evolve under 21st Century Cures, new customers and sources of data, and new FDA guidance. The dearth of enforcement letters can imply 'anything goes' but DOJ/False Claims investigations and settlements, CIAs, etc., suggest otherwise. FDA and other government enforcement trends will be discussed, including a review of cases involving whistle blowers , DOJ, False Claims Act, Lanham Act and CIAs. In this “point – counterpoint” session, attendees will be equipped with a greater understanding of the environment which will contribute to better decision making when assessing advertising and promotional activities and materials and the potential unintended implications today.
    Learning Objective : Evaluate the regulatory, legal, and compliance environment for prescription drug and medical device advertising and promotion in the context of First Amendment case law; Apply key factors to making well-informed assessments of risk and communication of impact in proposed promotion and advertising tactics and promotional material.
      Coleen  Klasmeier, JD


      Coleen Klasmeier, JD

      • Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice
      • Sidley Austin, LLP, United States
      Alan G. Minsk, JD


      Alan G. Minsk, JD

      • Partner, Head of Food and Drug Team
      • Arnall Golden Gregory LLP, United States