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Accelerating CMC Workshop
Session 2: Update on ICH Q12
Session Chair(s)
Frank Montgomery, PhD
- Global Head Regulatory CMC, GRAPSQA
- AstraZeneca, United Kingdom
Ursula Busse, PhD, MBA
- Head of Regulatory Intelligence & Policy
- Boehringer Ingelheim, Germany
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
- Manager, Radiopharmaceuticals and Monoclonal Antibodies Division
- Health Canada, Canada
Feedback from the FDA pilot on established conditions
Christopher Downey, PhD
- Review Chief, OBP, OPQ, CDER
- FDA, United States
Learnings and challenges from the Implementation of ICH Q12
Stuart Finnie, DrSc, MS
- Director, CMC Regulatory Affairs
- AstraZeneca, United Kingdom
Industry Proposal on EU Variations
Simon Bennett, MSc
- Director, EU Regulatory Policy
- Biogen, United Kingdom
Panel discussion with Q&A
Brian Dooley, MPharm, MSc
- Quality Specialist
- European Medicines Agency, Netherlands
Contributing Panelist
Abdullah M. Alrashed
- Scientific Evaluation Specialist II
- Saudi Food and Drug Authority, Saudi Arabia
Contributing Panelist
Raphael Sanches Pereira
- Health and Regulation Expert / Office Manager
- ANVISA, Brazil
