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2020 ISPE Biopharmaceutical Manufacturing Virtual Conference


Application of ICH Q12 Principles in Modern CMC Submissions


Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Description

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):

Speaker(s):

  • Nina Cauchon, PhD, Director Regulatory Affairs - CMC, Amgen
  • Michael Cohen, PhD, Research Fellow - Global Chemistry, Manufacturing, and Controls, Pfizer Worldwide R&D

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