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Session 5 Track A: Communicating Product Risk in Today’s Evolving Regulatory Landscape
Session Chair(s)
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)
Speaker
Christine Novak, PharmD
Bristol-Myers Squibb, United States
Associate Director, Commercial Regulatory Affairs
Speaker
Dwight Bowen, PharmD, RPh
Apellis Pharmaceuticals, United States
Director, Regulatory Affairs Advertising & Promotion
Speaker
John Kamp
Coalition For Healthcare Communication (CHC), United States
Washington Counsel
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