Parallel Session 1 - Implementing ICH Q12: Industry and Regulator's Experiences

While the implementation of ICH Q12 tools and enablers across the US, EU, Japan, Canada, Switzerland and other ICH member countries is under way, it is recognized that the global regulatory authorities are at different stages of incorporation of ICH Q12 principles and tools, which in itself can pose challenges. This session will be focused on real life examples pertaining to ECs, PACMPs, PLCM documents and the PQS from global ICH Q12 related pilot programs and submissions to health authorities to help understand the benefits and challenges associated with this enhanced framework. The understanding gained would facilitate effective, predictive management and operational flexibility of post-approval lifecycle changes thus enabling timely access of high quality, safe, and effective medicines to patients while reducing unnecessary cost, time, and burden on industry and regulators.