×
Back to Agenda
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
Director Regulatory Affairs CMC, Amgen, United States
Facilitator
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Facilitator
Director, Continuous Manufacturing, Patheon, A Part of Thermo Fisher Scientific, United States
Facilitator
Deputy Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA, FDA, United States
Facilitator
Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA, United States
Have an account?