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Application of ICH Q12 Principles in Modern CMC Submissions
Application of ICH Q12 Principles in Modern CMC Submissions This session brings together industry and regulatory agency representatives to discuss case studies involving the implementation of ICH Q12 principles in regulatory submissions to facilitate post-approval CMC changes in an efficient and predictable manner.
FDA Perspective on the Implementation of ICH Q12
Pietro Perrone, PE Terrance Ocheltree, PhD, President
PharmTree Consultants
ICH Q12 and Beyond: The Journey Towards Regulatory Convergence in Product Life Cycle Management
Nina Cauchon, PhD, Director, Regulatory Affairs – CMC
Amgen Inc.
Application of ICH Q12, Established Conditions, and a Product Life Cycle Management Document to the Analytical Aspects of the 2019 FDA Q12 Pilot Program
Michael Cohen, PhD, Research Fellow – Global CMC
Pfizer
Extended Panel Q&A/Discussion
Nina Cauchon, PhD, Director, Regulatory Affairs – CMC
Amgen Inc.
Michael Cohen, PhD, Research Fellow – Global CMC
Pfizer
Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality
Novo Nordisk
Leader/Speaker(s):
Terrance
Ocheltree,
President, Executive Director - CMC Regulatory,
PharmTree Consultants
Speaker(s):
Nina
S. Cauchon,
PhD,
Director Regulatory Affairs - CMC,
Amgen Inc.
Michael
Cohen,
PhD,
Research Fellow - Global Chemistry, Manufacturing, and Controls,
Pfizer Worldwide R&D
Credits
Credits: None available.
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