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Session 4: Medical and Scientific Communication: Examining Recent Developments and Maintaining the Distinction from Promotion
Session Chair(s)
Mark Gaydos
Head of Labeling and Advertising & Promotion, Global Regulatory Science
Moderna, 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will examine recent developments in the area of medical and scientific communications, specifically the FDA’s recent draft guidance documents covering 1) communications to health care professionals regarding scientific information on unapproved uses and 2) addressing misinformation found in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Learning Objective : - Explain the key principles outlined in the FDA’s recent draft guidance documents relevant to medical and scientific communications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)
FINAL Guidance: Updates from FDA on SIUU
Janet Gottlieb, PhD
Canopy Life Sciences, United States
Head of Medical Review Solutions
Addressing Misinformation About Medical Devices and Prescription Drugs Draft Guidance
Gina L. Vestea, PharmD
Sanofi, United States
Head, Global Regulatory Affairs Advertising & Promotion
(Some) Non-FDA Issues to Consider with Product Promotion
Alan G. Minsk, JD
Arnall Golden Gregory LLP, United States
Partner, Head of Food and Drug Team