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Session 2: Update on ICH Q12
Session Chair(s)
Frank Montgomery, PHD
Global Head Regulatory CMC, GRAPSQA, AstraZeneca, United Kingdom
Ursula Busse, PHD, MBA
CMC Regulatory Affairs Advisor, Self employed, France
Countries are now progressing through the implementation process for Q12 with FDA step 5 publication, EU prioritising review of the Variations regulation and progress in Japan. The session will provide the regulators an opportunity to describe progress both within the IWG and in the regions to fully implement this critical guideline.
Speaker(s)
Hugo Hamel, MBA, MSC
Associate Director, BRDD, Health Canada, Canada
Implementation Challenges for ICH Q12: A Regulatory Perspective
Dr. Christopher Downey
Division Director, Pharmaceutical Manufacturing Assessment VI, OPMA, CDER, US FDA, United States
Feedback from the FDA pilot on established conditions
Stuart Finnie, DRSC, MS
Senior Director, CMC RA Policy and Advocacy, Gilead Sciences, United Kingdom
Learnings and challenges from the Implementation of ICH Q12
Simon Bennett, MS
Director, EU Regulatory Policy, Biogen, United Kingdom
Industry Proposal on EU Variations
Brian Dooley, MPHARM, MSC
Pharmaceutical Quality Senior Specialist, European Medicines Agency, Netherlands
Panel discussion with Q&A
Abdullah M. Alrashed
Senior Scientific Evaluation Expert, Saudi food and Drug Authority, Saudi Arabia
Contributing Panelist
Raphael Sanches Pereira
General Manager of the Office for Medicines, ANVISA, Brazil
Contributing Panelist
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