Learning Tracks

ICH Q12:  Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Industry and FDA Perspectives

Wednesday, November 10, 2021

1:00 p.m. - 2:30 p.m.

The intent of the ICH Q12 is to provide a flexible framework to facilitate the management of post approval CMC changes across the product lifecycle, in a more predictable and efficient manner, based on Quality by Design (QbD) principles and product and process understanding.   This increased flexibility should enable both industry and regulators to bring benefits to patients by reducing drug shortages, support continuous improvement and facilitate innovation.  In order to achieve this, it will require more harmonization/convergence amongst regulators regarding their adoption of ICH Q12 concepts, as well as industries effective implementation of the ICH Q12 tools and enablers.  In this session we would like to learn more regarding the following:

  • How is the Agency working with other regulatory bodies to further harmonize the adoption of the ICH Q12 concepts?
  • How does the US legal framework support the ICH Q12 implementation or does it present roadblocks?
  • What is the Agency’s expectation of how industry should implement the ICH Q12 tools?
  • How will the Agency allow industry to utilize a science and risk based approaches including prior knowledge in managing post approval activities in an efficient manner?
  • An industry perspective on the benefits and challenges of ICH Q12.

Moderator: Michael Banks
Senior Vice President, Global Head Regulatory Affairs R&D, Teva Pharmaceuticals

Mohamed Chan
Global Director, Manufacturing Technical Services, Apotex Inc.

CDR Mahesh Ramanadham, PharmD, MBA 
Senior Science and Policy Advisor, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER FDA

Rakhi Shah, PhD 
Branch Chief, Division of Pharmaceutical Manufacturing Assessment I, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, FDA

Janet Vaughn
Vice President North America Gx Regulatory Affairs, Teva Pharmaceuticals