Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle
Join our experts, and by attending this webinar, you will:
- Gain a clearer understanding of the updates in ICH Q2 (R2) and Q14, as well as the primary challenges these guidelines pose throughout the analytical lifecycle.
- Explore opportunities to leverage the improved approach for more efficient, science- and risk-based analytical development, including smarter utilisation of development and validation data.
- Assess the potential long-term effects of widespread Q2/Q14 adoption on industry practices, regulatory engagement, and the shift towards a more adaptable and sustainable analytical lifecycle.
- Explore the role of established conditions within ICH Q2(R2) and Q14, and their impact on lifecycle flexibility, regulatory expectations, and method robustness.
Event Overview
This webinar will examine the opportunities and challenges posed by ICH Q2(R2) and Q14, highlighting what’s new and why it matters for the analytical lifespan. We will discuss how the improved approach supports a more efficient lifecycle, covering practical topics such as reusing development data in validation studies and questioning whether established conditions are the ultimate answer. Lastly, we’ll explore future directions for these concepts, offering a forward-looking perspective on the next phase of analytical development and lifecycle management.
What you need to know:
Dual-time broadcast, with starting times as follows:
Wednesday, 25 March 2026
- Broadcast #1 (Europe / Asia): 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 (North America / Europe): 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’.
- If you’re unable to join the live broadcast, register anyway, and we’ll send you the recording.
- Join the BioQC user community for ongoing discussions after the event.
Who should attend?
Anyone interested in method development, validation, quality control, and lifecycle management involved in compliance, validation oversight, and interpretation of evolving ICH guidelines, whether for practical use or regulatory compliance, within biopharmaceutical analysis.
- Quality Control Scientists
- Analytical Development Scientists and Analytical Chemists
- CMC or Analytical Lifecycle Management Leads
- Quality Assurance (QA) professionals
- Regulatory Affairs and CMC Regulatory Specialists
- Technical or Scientific Managers, including Heads of Analytical Functions
Related events as part of the webinar series
Register now:
- Platform Analytical Procedures, beyond the technical challenges – coming!
Jean-Francois DierickStrategic Analytical Validation and Lifecycle LeadGSK (Belgium)Giovanni VitaliQC Analytical Method Validation Senior Lead - Global QCGSK (Italy)
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Dr. Ewoud van TrichtScientific DirectorBioQCExpert 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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