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Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

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Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycleJean-Francois Dierick, PhD

Panel Discussion

Presenters / Panellists

Presenters / Panellists
Jean-Francois 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).

Moderator

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.

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