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

Register at: bio-qc.com

Join our experts, and by attending this forum, you will:

• Benefit from in-depth knowledge sharing and insightful discussions for a deeper understanding of ICH Q14.
• Learn about the shifting regulatory landscape on analytical method development and the benefits of implementing enhanced method development approaches according to ICH Q14.
• Gain an understanding of the critical challenges and overcome those to lower the threshold of implementing ICH Q14 in your organisation.

Event Overview

Day 1: Overview of the ICH Q14 Guideline (26 March 2025)

A comprehensive overview of the ICH Q14 Guideline, including insights into its creation, the changing regulatory environment, and the importance of method development and validation. The panel discussion will highlight the scope and critical aspects of the guideline, emphasising its significance in ensuring an enhanced risk-based approach for developing analytical procedures. Within organisations, the reception of ICH Q14 varies, with some actively implementing it as a new approach to enhance analytical procedures while others view it as simply repackaging existing practices. The discussion will reflect on the balance between innovation and familiarity in regulatory compliance and analytical method development.

Day 2: Key Challenges and Solutions in Implementing ICH Q14 (2 April 2025)

Gain insights to implement ICH Q14 focusing on critical aspects such as the Analytical Target Profile (ATP), Knowledge and Risk Management, and the Analytical Procedure Control Strategy. Learn how these components play a crucial role in enhancing the quality of analytical procedures and ensuring robust method development and validation processes. The panel discussion will highlight the importance of setting clear analytical targets, managing knowledge and risks effectively, and developing a comprehensive control strategy to meet regulatory expectations and drive continuous improvement in analytical method development.

What you need to know:

Day 1: 26 March, 2025

Day 2: 2 April, 2025

Each day has a dual-time broadcast, with starting times as follows:

• Broadcast #1: 09:00 h GMT (London) / 10:00 h CET (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
• Broadcast #2: 08:00 h PST (Los Angeles) / 11:00 h EST (New York) / 16:00 h GMT (London) / 17:00 h CET (Paris/Berlin)

Duration: Approximately 60 – 90 minutes, incl. Q&A.

• Registrants attending this online event’s live broadcast sessions will receive a ‘Certificate of Attendance’.
• Join the BioQC user community for ongoing discussions after the event.

Who should attend?

Anyone interested in analytical procedure development, both practical and regulatory, as required within pharmaceutical and biopharmaceutical analysis. This event provides a comprehensive guide to navigating the challenges in implementing and complying with the ICH Q14 guideline, ensuring attendees leave with actionable insights for improving their method development processes.

• Industry experts involved in analytical procedure development and validation
• Industry experts involved in compliance and analytical method lifecycle management
• Quality control/quality assurance personnel
• Regulatory affairs professionals
• Academics interested in learning about method development and the regulatory requirements in the pharmaceutical and biopharmaceutical industry

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.

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