CMC Regulatory Science Forum
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Industry• AcademiaRegulators

ICH Q12 & Lifecycle Management of Pharmaceutical Products

Important Notice:

Due to a number of unforeseen circumstances, the ICH Q12 and Life-Cycle Management Workshop has been postponed until a later date in 2020. We apologise to speakers and attendees who had been anticipating this event. Please continue to visit the website for information on when and where the re-scheduled event will be hosted.

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

Hosted by the CMC Regulatory Science Forum in Partnership with Dublin City University

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.

Objectives:

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).