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Effective Communication Model Between Drug Safety, Regulatory Affairs, and Clinical Development
Session Chair(s)
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Amgen Inc., United States
This session reviews ideal interactions between regulatory affairs, safety, and clinical development in order to avoid noncompliance. Effective communication between safety, regulatory affairs, and clinical is key to address issues arising during development and postapproval.
Learning Objective : Discuss the development and implementation of an effective communication model between drug safety, regulatory affairs, and clinical development; Discuss establishing communication channels prospectively to address safety and regulatory issues during development and postapproval labeling updates when there are different marketing authorization holders in different territories.
Speaker(s)
An Ideal Model to Avoid Non-Compliance
Firoz Nilam, MS
Nilam Pharmaceutical Consulting Inc., United States
President
How to Optimize Safety Interactions and Collaborations
Mariette Boerstoel-Streefland, MD, MBA, MS
Bristol-Myers Squibb Company, United States
Senior Vice President, Worldwide Safety Officer
Regulatory Affairs Department Short Falls and Resolutions Towards the Ideal Model
Thomas Felix, MD
Amgen Inc., United States
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
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