Concurrent Session: ICH Q12 Implementation Progress and Future Opportunities | ICH Q12 is a truly transformational guideline that has a wide scope of applicability across the pharmaceutical development lifecycle and can help streamline the post-approval change management process by promoting the adoption of flexible science- and risk-based approaches. While in some markets full ICH Q12 implementation is well underway, in other markets ICH Q12 adoption has been partial or lagging. Further, potential lack of global convergence and alignment on ICH Q12 implementation approaches creates a risk of divergent implementation strategies among health authorities, placing an additional burden on the applicants and making the overall process less efficient. This session will summarize progress made to date on the global implementation of ICH Q12 and reflect on the remaining challenges and future opportunities to accelerate its adoption across the different regions. Featuring both industry and regulatory presenters, the session will help foster the open industry-regulator dialogue on the path forward to the global ICH Q12 adoption and help draw attention to the remaining implementation challenges and roadblocks.
Manager, Biotherapeutic Quality Division,