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ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality
Session Chair(s)
Amanda Marie Roache, MS
Senior Director, Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (PhRMA), United States
This session will provide an overview of ICH quality topics instrumental to the harmonization of pharmaceutical development and manufacturing standards and an introduction to the new and revised topics that are currently underway.
Learning Objective : Discuss the role of ICH quality topics in harmonizing standards for more efficient pharmaceutical development and manufacturing; Explain current ICH guidelines being revised, new guidelines being developed, and their anticipated impact to pharmaceutical development and manufacture.
Speaker(s)
ICH Strategy to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
Ashley Boam, MS
FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Industry Perspective on ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Produce Lifecycle Management
Andrew Chang, PhD
Novo Nordisk, United States
Vice President, Quality and Regulatory Compliance
Q2(R2)/Q14 Analytical Procedure Development and Validation
Nina S. Cauchon, PhD
Amgen, United States
Director Regulatory Affairs CMC
Q13 Continuous Manufacturing
Sau L Lee, PhD
FDA, United States
Deputy Super Office Director, OPQ, CDER
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