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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)
Implementation Challenges for ICH Q12: A Regulatory Perspective
Hugo Hamel, MBA, MSc
Health Canada, Canada
Associate Director, BRDD
Feedback from the FDA pilot on established conditions
Dr. Christopher Downey
US FDA, United States
Division Director, Pharmaceutical Manufacturing Assessment VI, OPMA, CDER
Learnings and challenges from the Implementation of ICH Q12
Stuart Finnie, DrSc, MS
Gilead Sciences, United Kingdom
Senior Director, CMC RA Policy and Advocacy
Industry Proposal on EU Variations
Simon Bennett, MSc
Biogen, United Kingdom
Director, EU Regulatory Policy
Panel discussion with Q&A
Brian Dooley, MPharm, MSc
European Medicines Agency, Netherlands
Pharmaceutical Quality Senior Specialist
Contributing Panelist
Abdullah M. Alrashed
Saudi food and Drug Authority, Saudi Arabia
Senior Scientific Evaluation Expert
Contributing Panelist
Raphael Sanches Pereira
ANVISA, Brazil
General Manager of the Office for Medicines