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This short course will discuss the basics of promotional review, a critical component of product marketing. Promotional review is more than ensuring materials meet regulatory, legal, and scientific requirements: there is an art to the communication and relationship-building to foster a collaborative environment that will increase efficiencies. Medical information has the unique opportunity to interpret guidance as it applies to evidence that can be used to support a claim and work as a collaborative partner with commercial. Participants will learn principles and tenets of medical review of promotional materials and apply them in an interactive workshop. This course will benefit those new to promotional review as well as offer an update to the more experienced reviewer

Learning objectives

At the conclusion of this session, participants should be able to:
  • Articulate the benefits and advantages of delegating medical information to promotional review
  • Identify substantiation and expectations of data requirements for product claims
  • Transition from reacting to content to a trusted collaborator
  • Apply principles of promotional material review and learnings from FDA enforcement letters in an interactive pharmaceutical website review