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Session 4: Adding Value to Ad Promo Review, Tips and Best Practices: Panel Discussion
Session Chair(s)
Victoria Tamarkin, MS
Founding Partner & President, Global Regulatory Affairs, Promotional Compliance
Victoria Tamarkin Consulting LLC, United States
Join a mock Medical/Legal/Regulatory (MLR) panel as they walk participants through their strategies for Ad Promo review. Panelists will explore case studies and discuss best practices for reviewing materials for different audiences and settings such as in social media and in convention booths at scientific congresses. Participants will learn how the panel views complex topics such as evaluating and applying the appropriate evidentiary standards that guide the review of different types of materials. Lastly, the panel will share best practices for effectively managing conflicting points of view and in this way furthering the contribution of each review discipline as part of a well-functioning promotional review committee.
Learning Objective : - Understand the types of medical, legal and regulatory considerations that apply to different types of materials and audiences including FDA Guidance, where applicable
- Gain confidence in knowing the types of questions that a reviewer will want to ask
- Find themselves better equipped on how to manage tension/conflict in Promotional Review Committees (PRCs)
- Learn practical tips to collaborate and add value within cross-functional MLR and Commercial teams
Speaker(s)
Speaker
Danielle Asuncion Carreon, MPH
Bristol-Myers Squibb, United States
Director, Regulatory Affairs
Speaker
William Aprea, JD
(former) Bristol-Myers Squibb, United States
Executive Director, Senior Franchise and Compliance Counsel
Speaker
Richard Gersh, MD
Merck & Co., Inc., United States
Executive Director, Global Medical Affairs