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Advancing ICH Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy , PhRMA, United States
Global leaders will convene to discuss the latest developments in the progression of harmonized ICH guidelines for pharmaceutical quality. This session will highlight the significance of guidelines currently under development and discuss considerations for their implementation. There will also be an opportunity for the audience to ask questions and engage with the original authors of these important guidelines.
Learning Objective : Describe the role of ICH quality guidelines in creating efficiency and allowing for the implementation of modern technologies, increased patient access, and fewer disruptions to manufacturing; Discuss ICH guidelines recently issued for public consultation and their anticipated impact; Discuss ICH’s multi-year strategy for modernization of ICH quality guidelines and what topic areas will be important for harmonization in the future.
Speaker(s)
Rick Friedman, MSC
Deputy Director, OMQ, Office of Compliance, CDER , FDA, United States
Q9(R1) Revision of ICH Quality Risk Management Framework to Support More Proactive Approach to Continual Improvement
Roger Nosal, PHD
Vice President, Head of Global CMC, Pfizer Inc, United States
ICH Quality Discussion Group and the Future of Quality Guidelines
Wendy Zwolenski-Lambert, MSC
Director, Regulatory Affairs CMC Strategy and Policy, Novartis Pharma AG, Switzerland
Q13 Continuous Manufacturing to Improve Efficiency, Agility, and Flexibility of Pharmaceutical Manufacturing
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