CMC Regulatory Science Forum
12/13 September 2019 - Dublin

Industry• AcademiaRegulators

ICH Q12 & Lifecycle Management of Pharmaceutical Products

ICH Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”

With the new ICH Q12 guideline expected to reach step 4 of its approval process during the latter half of 2019, the CMC Regulatory Science Forum have brought together key EU members of the ICH Q12 Expert Working Group, as well as senior regulators, industry experts and academics to discuss this new harmonised approach to management of post-approval changes in a more predictable and efficient manner across the product lifecycle.

This two day workshop will provide an overview of the principles, regulatory tools and enablers described in the guideline, as well as practical examples of how ICH Q12 can provide solutions to challenging areas of life-cycle management of CMC.

Why Should I Attend?

Top Experts in Europe in Attendance

We have brought together the best available expertise to discuss the topics in an open and impartial space. You will have the opportunity to discuss with key members of the ICH Q12 expert working group, as well as leading voices in regulation, industry and academia.


Day 1:

  • Overview of the Q12 guideline - principles, regulatory tools and enablers.

  • Understanding of the challenges and opportunities for implementation of Q12 in the EU.

  • Increased awareness of challenges of life-cycle management of CMC (technical ) changes.

Day 2:

  • Practical application of Q12 principles and regulatory tools.

  • Illustrations how these can provide solutions to challenging areas of life-cycle management of CMC.

Topics Include:

This two-day workshop will explore all facets of ICH Q12 and its implementation including:

  • Viewpoints from regulators and industry relating to Q12 implementation.

  • Technical and regulatory challenges.

  • Considerations for vaccine manufacturers.

  • Lifecycle management for PRIME and breakthrough designation procedures.

  • Novel and emerging analytical methodologies.

  • Continuous Manufacturing.

  • Lifecycle management of analytical techniques (use of predictive and mathematical models).



12/13 September 2019


All Hallows Campus, Dublin City University, Drumcondra, Dublin, D09 N920


Headline speakers include

Dr. Jean Louis Robert Former chair of EMA QWP. EU Member of ICH Q12 EWG.

Dr. Nick Lee CMC Assessor for HPRA

Dr. Graham Cook Pfizer, EFPIA/EBE member of ICH Q12 EWG

Dr. Markus Goese Roche, EFPIA/EBE member of ICH Q12 EWG

Dr. Kevin O'Donnell Market Compliance Manager, HPRA

Dr. Thierry Gastineau Sanofi Pasteur & Vaccines Europe