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Session 6A: Post Approval Changes - ICH Q12
Session Chair(s)
Jean-Louis Robert, PhD
Former CHMP/CVMP QWP Chair
Luxembourg
This session will present the challenges related to regulatory management of post approval changes. Many of the challenges are due to differences in the global regulatory requirements and complexities associated with supply chain. Can ICH Q12 address these challenges? Is Q12 by itself sufficient? How can Q12 be accepted worldwide?
Speaker(s)
Post Approval Changes from a Regulatory Perspective
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
Post Approval Changes with Emphasis on Biological Products
Markus Goese
F. Hoffmann-La Roche Ltd, Switzerland
Head EU CMC Regulatory Policy
Post Approval Changes with Emphasis on Chemical Products with Global Supply Chains
Frank Montgomery, PhD
AstraZeneca, United Kingdom
Global Head Regulatory CMC, GRAPSQA