Course 2: Promotional and Medical Review Committee 101

概览

Short Course* Registration: 7:30AM-12:00PM

Promotional review is a critical component to the successful marketing of products. Promotional review committees ensure that a company’s advertising and promotional materials and activities meet regulatory, legal, and scientific requirements, and internal policies and guidelines. Medical information/communications can play a key role in ensuring scientific rigor and accuracy and clinical relevancy of the content. Topics relevant for medical communications professionals performing promotional review will be covered. The short course is primarily designed for the new reviewer, but also will serve as an excellent follow-on to the topics covered in the Primer course or as a refresher for the experienced promotional material reviewer. It will be highly interactive and will include in-depth reviews of promotional materials cited by the FDA.

*Short Courses are not included in the forum registration and require a separate fee.Return to Medical Affairs and Scientific Communications Forum

学习目标

At the conclusion of this short course, participants should be able to:

Apply principles of promotional materials review and learnings from FDA enforcement letters when reviewing and commenting on promotional materials
Apply FDA standards and expectations of data requirements
Determine acceptability of references used to support promotional claims
Explain the current regulatory, legal, and compliance environment for promotional materials and activities beyond FDA

Course 2: Promotional and Medical Review Committee 101

概览

学习目标

获得信息并保持参与