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ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy , 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)
Ashley Boam, MS
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
ICH Strategy to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
Andrew Chang, PhD
Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States
Industry Perspective on ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Produce Lifecycle Management
Nina S. Cauchon, PhD
Director Regulatory Affairs CMC, Amgen, United States
Q2(R2)/Q14 Analytical Procedure Development and Validation
Sau Lee, PhD
Deputy Super Office Director, OPQ, CDER, FDA, United States
Q13 Continuous Manufacturing
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