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Promotional Material Management: From Review to Submission – Contemporary Ideas

Medical Communication, Medical Writing, and Medical Science Liaison

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:

Room Number:



Promotional Material Management: From Review to Submission – Contemporary Ideas

Julia Petses, PharmD
Director, Medical Information Services Oncology/Hematology
Sanofi US, United States

A risk-based approach for the review of commercial materials to ensure they are truthful, accurate, and balanced, and not false or misleading will be discussed. A global perspective and the challenges of performing a global versus a country-specific review will be explored. Additionally, regulatory requirements in the US and around the world are impacting the traditional separation of promotional review and regulatory operations. Evaluating how this new paradigm will change the promotional review process is necessary to ensure efficiency, quality, and accuracy.

Learning Objective(s):
Explain different approaches for the review of promotional materials; Identify key considerations when reviewing global materials; Describe the relationship between promotional review and regulatory operations.

Presentation(s) & Speaker(s):
Optimization of the Promotional Review Process
Robert K. Morris, PharmD
Director, Medical Information, HIV and Dermatology
GlaxoSmithKline, United States

The Benefits and Risks with Global Promotional Review
Victoria Dlensi
Associate Director, Neuroscience
Shire AG, Switzerland

Marketing Globally Means Complying Regionally: How Promotional Review and Regulatory Affairs are Becoming More Integrated to Support Regional and Global Requirements
Dirk Karston Beth
Managing Director
Mission3, United States