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Update on ICH Quality Topics
Session Chair(s)
Olivia Shopshear, MS
Senior Director, US Regulatory Policy Lead, Biogen, United States
This session will provide updates on ICH’s efforts to develop new and revised globally harmonized guidelines related to product quality and regulatory CMC topics. Topics include Lifecycle Management, Continuous Manufacturing, and Analytical Methods.
Learning Objective : Identify the technical and regulatory issues under discussion in ICH as they related to regulatory CMC and product quality topics; Discuss various perspectives from the expanded ICH membership on the impact, opportunities and challenges for the new and ongoing ICH Quality Topics.
Speaker(s)
ICH Quality Vision and Context Setting
Director, Regulatory Policy; Legal and Regulatory, Flatiron Health , United States
M9 and IQDG
Vice President, Head of Global CMC, Pfizer Inc, United States
Q2(R2) - Analytical Procedure Validation / Q14 - Analytical Procedure Development
Vice President, Sanofi, United States
Q12
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Q13
Head of External Affairs (Quality), Merck & Co., Inc., United States
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