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Session 4 Track A: Patient-Centric Quality Standards
Session Chair(s)
Christine Moore, PhD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
Patient Centric Quality Standards is an evolving approach for setting pharmaceutical quality requirements based upon a wide array of scientific data. The traditional approach of setting drug specifications from limited manufacturing experience can lead to unnecessarily narrow specifications that can jeopardize future ability to successfully manufacture the product. Use of prior knowledge and product specific knowledge can provide justification for wider, yet appropriate drug specifications and support continued supply of quality product to patients.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the potential issues related to specification setting based upon limited manufacturing data
- Understand the role of prior knowledge and product specific knowledge in specification setting
- Provide examples of how scientific data can be applied toward specification setting
Speaker(s)
Speaker
Shrinivas K Murti, PhD, MBA
Merck, United States
Director, Regulatory Affairs CMC
Patient-Centric Quality Standards: Impurity Specifications
Roger Quan
Abbvie, United States
Senior Director, Regulatory Affairs CMC
Prior Knowledge in Setting Patient Centric Specifications
Anthony Mire-Sluis, PhD
Astrazeneca, United States
Head of Global Quality
Patient Centric Quality Standards
Lawrence Yu, PhD
FDA, United States
Director, Office of New Drug Products, OPQ, CDER