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Session 6 Track 1: Considerations Pertaining to Medical-commercial Collaborations Including PRC and MRC
Session Chair(s)
Darshan Kulkarni, JD, PharmD, MS
Principal Attorney
Kulkarni Law Firm, PC, United States
This session will discuss the importance of cross-functional collaboration between medical communication and advertising and promotion functional areas within an organization. This session will provide an overview of the overall training and auditing needed for promotional review committees (PRC), medical, legal, and regulatory (MLR) review, or MRC review to ensure compliance of external and internal regulations and guidelines for the marketing and promotion of materials for one’s company and organization. We will consider not only US but also Canadian considerations.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify essential training opportunities for PRC Committees
- Appraise auditing processes available to review PRC Committee processes
- List regulations and guidelines that are essential and relevant for promotional materials
Speaker(s)
Speaker
Randy Levitt, PhD
Knight Therapeutics Inc., Canada
Director, Pharmacovigilance, Medical Information and Patient Support
Speaker
Allyson Chambers
Alkermes, United States
Director, Regulatory Affairs Advertising & Promotion
Speaker
Payal Desai, PharmD
Janssen Scientific Affairs, LLC., United States
Associate Director, Integrated Evidence Team Lead