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Gaylord Palms Resort & Convention Center

Mar 21, 2016 8:30 AM - Mar 21, 2016 12:00 PM

6000 West Osceola Parkway, Kissimmee, FL 34746

Tutorial 2: Promotional and Medical Review Committee 101

Overview

Tutorials are not included in the meeting registration and require a separate registration fee

Tutorial Registration: 7:30am-8:30am

Promotional review is a critical component to successful marketing of products. 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. 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 tutorial may be a follow on to the topic covered in Core Curriculum or a refresher for the experienced promotional material reviewer, and will include table breakouts for in-depth reviews of promotional materials such as mock-ups and those cited by the FDA.

Learning objectives

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

Apply principles of promotional materials review and learnings from FDA warning letters when reviewing and commenting on promotional materials
Determine acceptability of data/references used to support promotional claims
Explain how promotional materials play a role in Corporate Integrity Agreements (CIAs)
Describe an oversight review process for promotional materials and understand how PRC team members prepare for an oversight/escalation meeting

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Tutorial 2: Promotional and Medical Review Committee 101

Overview

Learning objectives

Be informed and stay engaged.