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Where Quality Meets Safety and Efficacy: An Interactive Experience
Session Chair(s)
Christine Moore, PhD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
This workshop will discuss patient-focus quality standards, also known as clinically-relevant specifications, and how it provides an approach to specification setting that is based on patient need, rather than manufacturing history.
Learning Objective : Describe what is meant by patient-focused quality standards and how these approaches can impact specification setting and continual improvement efforts.
Speaker(s)
Facilitator
Nina S. Cauchon, PhD
Amgen, United States
Director Regulatory Affairs CMC
Facilitator
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Facilitator
Eric Jayjock, PhD
Patheon, A Part of Thermo Fisher Scientific, United States
Director, Continuous Manufacturing
Facilitator
Geoffrey Wu, PhD
FDA, United States
Deputy Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Facilitator
Paul Seo, PhD
FDA, United States
Director, Division of Biopharmaceutics, ONDP, OPQ, CDER
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