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Radisson Blu

20 jun 2018 7:45 a.m. - 21 jun 2018 5:00 p.m.

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

Session 6A: Post Approval Changes - ICH Q12

Session Chair(s)

Jean-Louis  Robert, PhD

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)

Jean-Louis  Robert, PhD

Post Approval Changes from a Regulatory Perspective

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

Markus  Goese

Post Approval Changes with Emphasis on Biological Products

Markus Goese

F. Hoffmann-La Roche Ltd, Switzerland

Head EU CMC Regulatory Policy

Frank  Montgomery, PhD

Post Approval Changes with Emphasis on Chemical Products with Global Supply Chains

Frank Montgomery, PhD

AstraZeneca, United Kingdom

Global Head Regulatory CMC, GRAPSQA

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