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Advertising and Promotion Regulatory Affairs Conference


Session 5 Track A: Communicating Product Risk in Today’s Evolving Regulatory Landscape

    Session Chair(s)
      Christine  Novak, PharmD

      Christine Novak, PharmD

      • Associate Director, Commercial Regulatory Affairs
      • Bristol-Myers Squibb, United States
    Pharmaceutical companies are constantly evaluating the appropriate balance and presentation of risk and benefit information within promotional material. This has proved to be a constant challenge for pharmaceutical companies in regards to certain types of promotional material. This session will discuss some of the recent developments regarding how a product’s risk information could be communicated- with a focus on the presentation of risk information in materials directed towards consumers.
    Learning Objective : Upon completion of this session, the participant should be able to:
    • Review historical disclosure of risk information in consumer directed advertising
    • Evaluate a study designed to assess an alternative approach to presenting risk information within broadcast direct-to-consumer (DTC) prescription drug ads
    • Discuss the pros and cons of a potential new risk presentation within broadcast DTC prescription drug ads

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