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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
Camille Jackson
Flatiron Health , United States
Director, Regulatory Policy; Legal and Regulatory
M9 and IQDG
Roger Nosal, PhD
Pfizer Inc, United States
Vice President, Head of Global CMC
Q2(R2) - Analytical Procedure Validation / Q14 - Analytical Procedure Development
Nasir Egal, PhD
Sanofi, United States
Vice President
Q12
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Q13
Ganapathy Mohan, PhD
Merck & Co., Inc., United States
Head of External Affairs (Quality)
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