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Session 4: Medical and Scientific Communication: Examining Recent Developments and Maintaining the Distinction from Promotion
Session Chair(s)
Mark Gaydos
Former Global Head, Advertising & Promotion, Global Regulatory Affairs
Sanofi, United States
This session will examine recent developments in the area of medical and scientific communications, specifically the FDA’s recent draft guidance documents covering 1) communications to health care professionals regarding scientific information on unapproved uses and 2) addressing misinformation found in internet-based communications. Additionally, the session will explore the not always straightforward task of distinguishing and separating medical and scientific communications from advertising and promotion, including the functions involved in each and the often blurry line between factual scientific information and product claims. As part of the discussion, panel members will examine ways companies can compliantly and effectively engage in legitimate medical and scientific communication.
Learning Objective : - Explain the key principles outlined in the FDA’s recent draft guidance documents relevant to medical and scientific communications
- Differentiate between medical and scientific communications on the one hand and product promotion on the other
- Apply the aforementioned learnings within their respective organizations to help develop compliant medical and scientific communications
Speaker(s)
Speaker
Janet Gottlieb, PhD
Canopy Life Sciences, United States
Head of Medical Review Solutions
Speaker
Representative Invited
Arnall Golden Gregory LLP, United States
Speaker
Gina L. Vestea, PharmD
Sanofi US Inc., United States
Director, US Regulatory Affairs Marketed Products
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