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Implementation Progress of ICH Q12
Session Chair(s)
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.
Speaker(s)
Use of ICH Q12 Lifecycle Management Tool Post Approval Change Management Protocol for Biologics/Plasma-Derived Proteins
Dieter Brazel, PhD
CSL Behring GmbH, Germany
Senior Director, Technical and Strategic Area Lead, Plasma, GRA CMC
ICH Q12 Implementation Update and Reflections on the Established Conditions Pilot
Joel Welch, PhD
FDA, United States
Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER
Industry Update
Roger Nosal, PhD
Pfizer Inc, United States
Vice President, Head of Global CMC
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