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Virtual

Mar 06, 2023 10:00 AM - Mar 08, 2023 4:30 PM

(US Eastern Standard Time)

Latin America Annual Meeting

Latin America Annual Meeting is fully virtual. Join us from the comfort of your own space!

Session 7, Tracks A, B: ICH Q12 Implementation, Progress and Future Opportunities

Session Chair(s)

Flavia  Firmino Ribeiro, PharmD

Flavia Firmino Ribeiro, PharmD

Director Reg Global CMC

Pfizer, Brazil

Lorena  Larrosa, RPh

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)

Hugo  Hamel, MBA, MSc

Implementation Status of ICH Q12 in Canada

Hugo Hamel, MBA, MSc

Health Canada, Canada

Associate Director, BRDD

Raphael  Sanches Pereira

Implementation Status of ICH Q12 in Canada

Raphael Sanches Pereira

ANVISA, Brazil

Quality Assessment of Synthetic Medicines Office Manager

Timothy  Watson, PhD

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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