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Session 7, Tracks A, B: ICH Q12 Implementation, Progress and Future Opportunities
Session Chair(s)
Flavia Firmino Ribeiro, PharmD
Director Reg Global CMC
Pfizer, Brazil
Lorena Larrosa, RPh
Regulatory Affairs Manager
Abbvie, Uruguay
ICH Q12 is a transformational guideline that provides a framework to facilitate the management of post-approval chemistry, manufacturing, and control (CMC) changes in a more predictable and efficient manner, and by promoting the adoption of science- and risk-based approaches. While in some markets full ICH Q12 implementation is well underway, for others, ICH Q12 adoption has been partial or stepwise. The efforts toward global regulatory harmonization of product control strategies and CMC content are essential to accelerate the delivery of innovative therapeutics to millions of patients around the globe. Regulatory divergence leads to modifications to control strategy that in turn leads to multiple regional and local control strategy variants globally.
This session will summarize progress made to date on the implementation of ICH Q12 in Canada and Brazil, reflect on the challenges and future opportunities to accelerate its adoption across the different regions, and discuss the value of improvement toward global harmonization of control strategies.
Learning Objective : - Identify the different regulatory strategies on ICH Q12 implementation, based on local regulatory environments and complexities
- Recognize the importance of implementing Q12 (partial or total) across different markets
- Identify the value of improvement toward global harmonization of control strategies to enable accelerated drug development and to ensure product supply and continual improvement through efficient lifecycle management
Speaker(s)
Implementation Status of ICH Q12 in Canada
Hugo Hamel, MBA, MSc
Health Canada, Canada
Associate Director, BRDD
Implementation Status of ICH Q12 in Canada
Raphael Sanches Pereira
ANVISA, Brazil
Quality Assessment of Synthetic Medicines Office Manager
Toward a Single Global Control Strategy: Industry Study
Timothy Watson, PhD
Gilead Sciences, United States
Vice President- Head of CMC Regulatory Affairs
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