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Monday, June 28 • 4:00pm - 5:00pm
#152 SL: Implementation Progress of ICH Q12

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-556-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Ingrid Markovic, PhD


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

ICH Q12 Implementation Update and Reflections on the Established Conditions Pilot
Joel Welch, PhD

Industry Update
Roger Nosal, PhD

avatar for Ingrid Markovic

Ingrid Markovic

Senior Science Advisor for CMC, Office of the Center Director, CBER, FDA, United States
Ingrid Markovic, Ph.D. serves as the CMC Policy Lead in the CBER Office of the Center Director where she spearheads CMC Policy activities partnering with internal and external stakeholders to ensure consistent interpretation and application of CMC policies and programs. In the international... Read More →
avatar for Dieter Brazel

Dieter Brazel

Senior Director, Technical and Strategic Area Lead, Plasma, GRA CMC, CSL Behring GmbH, Germany
After obtaining his Diploma in Chemistry Dieter Brazel has earned a Ph.D. from Stuttgart University (thesis Max Planck Institute for Biochemistry). Further he holds a Masters in Regulatory Affairs in Regulatory Affairs University of Bonn. He has spent his entire career in the biopharmaceutical... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →

Joel Welch

Associate Director for Biosimilar& Regulatory Strategy, OBP, OPQ, CDER, FDA, United States
Joel Welch is the Associate Director for Biosimilar & Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies... Read More →

Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session