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DIA 2021 Global Annual Meeting

Implementation Progress of ICH Q12

Session Chair(s)

Ingrid  Markovic, PhD

Ingrid Markovic, PhD

  • Senior Science Advisor for CMC, Office of the Center Director, CBER
  • FDA, United States
This guideline provides a globally agreed framework to facilitate the management of such post-approval CMC changes in a predictable and efficient manner across the product lifecycle. A globally harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.
Learning Objective : Define the application of Q12 principles that enable managing post-approval changes in a more predictable and efficient manner; Define key opportunities and challenges with Q12 implementation from industry and regulatory experts; Explain from the real-life case studies applying Q12 principles; Discuss learnings from the Established Conditions pilot.


Dieter  Brazel, PhD

Use of ICH Q12 Lifecycle Management Tool Post Approval Change Management Protocol for Biologics/Plasma-Derived Proteins

Dieter Brazel, PhD

  • Senior Director, Technical and Strategic Area Lead, Plasma, GRA CMC
  • CSL Behring GmbH, Germany
Joel  Welch, PhD

ICH Q12 Implementation Update and Reflections on the Established Conditions Pilot

Joel Welch, PhD

  • Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER
  • FDA, United States
Roger  Nosal, PhD

Industry Update

Roger Nosal, PhD

  • Vice President, Head of Global CMC
  • Pfizer Inc, United States