WEBINAR SERIES
Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle
On-Demand Presentation | With experts from GSK
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.
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
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Presenters / Panellists
Jean-François Dierick, PhDStrategic Analytical Validation and Lifecycle LeadGSK (Belgium)Jean-Francois Dierick holds a PhD in Biology from the University of Namur (Belgium) in the field of cellular ageing proteomics, and a post-doc in proteomics from the University of Brussels (Belgium). Jean-Francois Dierick entered the pharmaceutical world at SGS, where he led the Biology Department (Biotechnology, Biochemistry, Cell Biology, Molecular Biology, Microbiology, Toxicology). In 2008, he joined GSK Vaccines, where he has held several positions in the analytics of biological products, both in development and in the commercial space. Today, he works at GSK as Strategic Analytical Validation and Lifecycle Lead / Vx Analytical R&D, leading the implementation of ICH Q2 and Q14.
Giovanni Vitali, MScQC Analytical Method Validation Senior Lead - Global QCGSK (Italy)Giovanni Vitali is a graduate in Pharmaceutical Chemistry from the University of Pisa (Italy). He joined GSK in 2016, where he held several roles within local Quality Control, gaining hands‑on experience across analytical operations and quality systems. Since 2022, Giovanni has been working in Global Quality Control as an Analytical Method Validation Senior Lead. In this role, he supports the definition and implementation of global strategies for analytical method validation, lifecycle management, and standardisation, with particular focus on alignment with evolving regulatory expectations, including ICH Q2(R2).
Jean-François Dierick, PhDStrategic Analytical Validation and Lifecycle LeadGSK (Belgium)Jean-Francois Dierick holds a PhD in Biology from the University of Namur (Belgium) in the field of cellular ageing proteomics, and a post-doc in proteomics from the University of Brussels (Belgium). Jean-Francois Dierick entered the pharmaceutical world at SGS, where he led the Biology Department (Biotechnology, Biochemistry, Cell Biology, Molecular Biology, Microbiology, Toxicology). In 2008, he joined GSK Vaccines, where he has held several positions in the analytics of biological products, both in development and in the commercial space. Today, he works at GSK as Strategic Analytical Validation and Lifecycle Lead / Vx Analytical R&D, leading the implementation of ICH Q2 and Q14.Giovanni Vitali, MScQC Analytical Method Validation Senior Lead - Global QCGSK (Italy)Giovanni Vitali is a graduate in Pharmaceutical Chemistry from the University of Pisa (Italy). He joined GSK in 2016, where he held several roles within local Quality Control, gaining hands‑on experience across analytical operations and quality systems. Since 2022, Giovanni has been working in Global Quality Control as an Analytical Method Validation Senior Lead. In this role, he supports the definition and implementation of global strategies for analytical method validation, lifecycle management, and standardisation, with particular focus on alignment with evolving regulatory expectations, including ICH Q2(R2).
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Moderator
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.
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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