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