Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development

Expert Forum

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Part 1: Overview of the ICH Q14 Guideline

ICH Q14 Analytical Procedure Development by Dr. Christof Finkler

Part 1: Overview of the ICH Q14 Guideline

Expert Forum Panel Discussion

Part 2: Key Challenges and Solutions in Implementing ICH Q14

Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile by Prof. Sandra Furlanetto

Part 2: Key Challenges and Solutions in Implementing ICH Q14

Critical Analytical Procedure Parameters and Risk Assessments by Dr. Cyrille Chéry

Part 2: Key Challenges and Solutions in Implementing ICH Q14

Analytical Procedure Control Strategy (ACPS) by Dr. Lars Geurink

Part 2: Key Challenges and Solutions in Implementing ICH Q14

Expert Forum Panel Discussion

Presenters / Panellists

Dr. Christof Finkler
F. Hoffmann-La Roche AG (Switzerland)
Senior Director CMC Policy – Technical Development Biotech

Prof. Sandra Furlanetto
University of Florence (Italy)
Professor of Analytical Chemistry

Dr. Cyrille Chéry
UCB (Belgium)
Associate Director

Dr. Lars Geurink
Batavia Biosciences (Netherlands)
Associate Director Assay Development

Moderators

Prof. Dr. Cari Sänger-van de Griend

Expert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.

Dr. Ewoud van Tricht

Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.