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CMC/GMP: Risk-Based Regulatory Review
Session Chair(s)
Roger Nosal, PhD
Vice President, Head of Global CMC
Pfizer Inc, United States
This forum will focus on presenting new and alternative strategies for use in implementing both risk minimization and risk mitigation processes in relation to CMC and GMP processes. In addition, we will focus on the benefits of implementing or modifying a product life cycle management program in both manufacturing and regulatory environments.
Learning Objective : Describe various risk strategies and their impact on CMC; Compare and contrast currently implemented risk strategies with alternative strategies in regards to minimizing and mitigating risk; Discuss subtopics such as risk assessment, risk characterization, and risk communication.
Speaker(s)
Panelist
Ganapathy Mohan, PhD
Merck & Co., Inc., United States
Head of External Affairs (Quality)
Panelist
Susan Rosencrance, PhD
FDA, United States
Acting Director, Office of Generic Drugs, CDER
Panelist
Lynne Krummen, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Technical Regulatory, Biologics
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Ways to register
Registration override should work.