Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14

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 Q2(R2)
• Learn about the shifting regulatory landscape on analytical procedures and the benefits of implementing enhanced method validation approaches according to ICH Q2(R2) and ICH Q14
• Gain an understanding of the key challenges of adapting to ICH Q2(R2) in your own organisation

Event Overview

Part 1:  Understanding the ICH Q2 Guideline (20 May, 2025)

The revised ICH Q2 guideline on analytical procedure validation provides a brief introduction to the evolving regulatory landscape and the expectations for method validation. It aims to harmonise the validation process and lifecycle management of analytical procedures alongside ICH Q14. One area of focus is the common gaps in filing packages for QC release and stability method validations.

Key additions for Day 1 discussions include:

• Analytical Target Profile (ATP) and its role in defining method development and validation objectives.
• Multivariate validation techniques and considerations for real-time release testing.
• Incorporating principles from ICH Q8 – Q12 to achieve robust and modern validation practices.

Part 2: Key Challenges and Solutions in Adapting to ICH Q2(R2) (27 May, 2025)  

Sharing of important aspects of validation in the field of analytical procedures: validation of multivariate analytical procedures, validation of platform technologies, and validation of bioanalytical methods. Each of these validation processes is crucial to ensuring the accuracy and reliability of analytical results in various scientific and technological fields.

Key additions for Day 2 discussions include:

• Practical examples and regulatory expectations for the validation of biotechnological analytical methods.
• Validation of cell-based assays and platform technologies, particularly for biological products.
• Strategies to align validation practices with enhanced approaches described in ICH Q14.

What you need to know:

Part 1: 20 May, 2025

Part 2: 27 May, 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 Q2(R2) guideline, ensuring attendees leave with actionable insights for improving their method development processes

• Industry experts involved in analytical procedure development and validation
• Stakeholders in method lifecycle management and regulatory compliance
• 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

To be confirmed.

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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