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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world

Session 2: Update on ICH Q12

Session Chair(s)

Frank  Montgomery, PhD

Frank Montgomery, PhD

  • Global Head Regulatory CMC, GRAPSQA
  • AstraZeneca, United Kingdom
Ursula  Busse, PhD, MBA

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.


Hugo  Hamel, MBA, MSc

Implementation Challenges for ICH Q12: A Regulatory Perspective

Hugo Hamel, MBA, MSc

  • Manager, Radiopharmaceuticals and Monoclonal Antibodies Division
  • Health Canada, Canada
Christopher  Downey, PhD

Feedback from the FDA pilot on established conditions

Christopher Downey, PhD

  • Review Chief, OBP, OPQ, CDER
  • FDA, United States
Stuart  Finnie, DrSc, MS

Learnings and challenges from the Implementation of ICH Q12

Stuart Finnie, DrSc, MS

  • Director, CMC Regulatory Affairs
  • AstraZeneca, United Kingdom
Simon  Bennett, MSc

Industry Proposal on EU Variations

Simon Bennett, MSc

  • Director, EU Regulatory Policy
  • Biogen, United Kingdom
Brian  Dooley, MPharm, MSc

Panel discussion with Q&A

Brian Dooley, MPharm, MSc

  • Quality Specialist
  • European Medicines Agency, Netherlands
Abdullah M. Alrashed

Contributing Panelist

Abdullah M. Alrashed

  • Scientific Evaluation Specialist II
  • Saudi Food and Drug Authority, Saudi Arabia
Raphael  Sanches Pereira

Contributing Panelist

Raphael Sanches Pereira

  • Health and Regulation Expert / Office Manager
  • ANVISA, Brazil