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Bethesda North Marriott Hotel and Conference Center

Mar 08, 2018 7:00 AM - Mar 09, 2018 3:00 PM

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

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

Speaker(s)

Christine  Novak, PharmD

Speaker

Christine Novak, PharmD

Bristol-Myers Squibb, United States

Associate Director, Commercial Regulatory Affairs

Dwight  Bowen, PharmD, RPh

Speaker

Dwight Bowen, PharmD, RPh

Apellis Pharmaceuticals, United States

Director, Regulatory Affairs Advertising & Promotion

John  Kamp

Speaker

John Kamp

Coalition For Healthcare Communication (CHC), United States

Washington Counsel

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