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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)
Speaker
Daniel Hill, MBA
Biogen, United States
Associate Director Digital Development and Analytics
Speaker
Nina S. Cauchon, PhD
Amgen, United States
Director Regulatory Affairs CMC
Panelists
Bryan Castle, PhD
Eli Lilly and Company, United States
Executive Director, Synthetic Molecule Design & Development
Panelists
Bogdan Kurtyka, PhD
FDA, United States
Senior Process Quality Assessor
Panelists
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
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