ICH delivers guidance on science- and risk-based strategies and is an enabler of greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. The ICH Q12 Lifecycle Management guideline provides a framework for managing post-approval changes. Global adoption and implementation of ICH Q12 continues to present challenges both for industry and regulators. Attendees will learn about the worldwide status of the implementation ICH Q12, with a particular focus on the benefits and challenges of putting into practice PACMPs and established conditions. The draft version of ICH Q14, the Analytical Procedure Development guideline, was released for public consultation in March 2022. Attendees will learn by example how statistical methods can be leveraged to most efficiently and effectively meet several fundamental aspects of analytical procedure lifecycle management described in this guideline. Introduction of the Quality - M4Q(R1) guideline on the Common Technical Document (CTD) in 2002 harmonized the format of quality information for registration of pharmaceuticals. Attendees will learn about important revisions to M4Q(R1) including improvements in registration and lifecycle management efficiency, leveraging digital technologies, and accelerating patient and consumer access to pharmaceuticals. This session will explore recent updates on ICH Q12, Q14 and M4Q through a series of five lightening talks followed by an interactive panel discussion that includes industry and regulatory agency subject matter experts.
1345-1350: Welcome, Announcements, Introductions by Connie Langer 1350-1402: Revision of ICH M4Q by Sarah Pope Miksinski 1402-1414: Analytical Procedure Lifecycle Statistical Practices by Tara Scherder 1414-1426: ICH Q12 Current Status, Challenges, and Opportunities by Eli Zavialov 1426-1438: The Benefits of Worldwide Acceptance of PACMPs in the Implementation of ICH Q12 Principles by Ben Stevens 1438-1450: ICH Q12: FDA Implementation Experience by Mahesh Ramanadham 1450-1515: Question and Answer/Panel Discussion moderated by Connie Langer