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Session 5 Track A: Accelerated Development – CMC Challenges and Best Practices
Session Chair(s)
Annie W Sturgess, PhD
Vice President, Global Regulatory Sciences, CMC
Bristol-Myers Squibb Company, United States
Several Health Authorities have implemented accelerated regulatory pathways intended to expedite the development and review of medicines that target an unmet medical need. The initial focus of these programs focused on acceleration of the clinical aspects of drug development. However, shorter clinical development programs can have significant impact on product and process development for the manufacturing organization. This session will focus on the Chemistry, Manufacturing, and Controls (CMC) aspects of accelerated drug development, including use of post approval change management protocols to support future lifecycle management changes.
Speaker(s)
Speaker
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER
PACMPs- Tool to Support Accelerated Development/Commercialization
Pramod Kotwal
Merck & Co., Inc., United States
Director
Accelerating CMC Development – Predictive Stability
Andrew Kuzmission
Vertex Pharmaceuticals, United States
Sr. Director, Global Regulatory Affairs