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Session 5 Track 3: ICH Q14 Regulatory Perspective and the Impact on Process Analytical Technology
Session Chair(s)
Claus Rentel, PhD
Vice President, Analytical Development and Quality Control, Ionis Pharmaceuticals, Inc., United States
A new quality guideline, ICHQ14, on analytical procedure development is being developed. The intent of this guideline is to harmonize scientific approaches of analytical procedure development in both traditional and enhanced approaches. Thus, resulting in improved regulatory communication between industry and regulators by facilitating efficient and science-based change management. The session will include presentations from a member of the working group as well as industry experience implementing PAT for an oligonucleotide therapeutic. The presentations will be followed by a panel discussion.
Learning Objective : - Understand concepts of an enhanced approach to analytical method development and Quality by Design (QbD) principles like Risk Assessment, Design Space, and Control Strategy
- Introduce ICH Q14 principles to analytical method validation
- Learn about applications of PAT and the use of multivariate models in oligonucleotide manufacturing
- Understand regulatory acceptance of strategies differing from traditional analytical method validations
Speaker(s)
Daniel Hill, MBA
Associate Director Digital Development and Analytics, Biogen, United States
Speaker
Nina S. Cauchon, PhD
Director Regulatory Affairs CMC, Amgen, United States
Speaker
Bryan Castle, PhD
Associate Vice President, Synthetic Molecule Design & Development, Eli Lilly and Company, United States
Panelists
Bogdan Kurtyka, PhD
Senior Process Quality Assessor, FDA, United States
Panelists
René Thürmer
Quality Assessor, Federal Institute for Drugs and Medical Devices, Germany
Panelists
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