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Session 8: ICH Q12 Implementation
Session Chair(s)
Frank Montgomery, PhD
Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom
Ben Thompson
Vice President, CMC and Non-clinical Regulatory Affairs
GlaxoSmithKline, United Kingdom
The session will explore the experience and plans for implementation of ICH Q12 across all ICH markets from both an industry and regulatory agency perspective. A further aspect will be a consideration of how to implement Q12 beyond ICH and the challenges to achieve this. The objective is to share learnings and opportunities to enable more effective implementation of ICH Q12
Speaker(s)
Industry Experience on ICH Q12
Stuart Finnie, DrSc, MS
AstraZeneca, United Kingdom
Director, CMC Regulatory Affairs
Industry Experience on ICH Q12
Gert Thurau, DrSc, PhD
F. Hoffmann-La Roche Ltd, Switzerland
Head of Manufacturing Technology Innovation in CMC Regulatory Policy
Emerging Markets Perspectives and Challenges - Feedback
Andrew Deavin, PhD, MS
GSK, Belgium
Senior Director, Regulatory Affairs
Health Authorities Perspective:
Brian Dooley, MPharm, MSc
European Medicines Agency, Netherlands
Quality Specialist
Health Authorities Perspective:
Mahesh R. Ramanadham, PharmD, MBA
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
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