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Session 11 Track A: Promotional Review Committees – Medical Communications as a Successful Team Member
Session Chair(s)
Ivy Chang, PHARMD
Director, Medical Information
Dompe US, United States
Promotional review committees (PRCs) ensure that a company’s advertising and promotional materials and activities meet regulatory, legal, and scientific requirements, and internal policies and guidelines. This session will discuss the latest FDA Notices of Violation and Warning Letters for promotional materials to highlight areas of promotional risk; the levels of evidence to consider when reviewing promotional materials; and tips and best practices for medical information/communications to become an effective and valued member of promotional review committees. Discussions will also highlight ‘soft skills’ needed to be a successful committee member.
Learning Objective : At the conclusion of this session, participants should be able to:
• Understand the areas of risk when making promotional claims
• Determine acceptability of references used to support promotional claims
• Advise on scientific and medical accuracy of promotional claims
• Ensure that promotional claims are adequately supported by substantial evidence
• Describe tips and best practices for becoming an effective and valued member of the promotional review committee
Speaker(s)
Faculty
Lois Jessen, PHARMD, MS, MSC
Otsuka Pharmaceutical Development and Communication, Inc., United States
Director, US Pharmaceuticals Law and Promotion Compliance
Faculty
Kristin Fox Goettner, PHARMD
Janssen Scientific Affairs, LLC, United States
Senior Director, Medical Information and Knowledge Integration
Faculty
Leslie McKay, PHARMD
Med Communications, Inc., United States
Content Medical Information Specialist