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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Marcel Hoefnagel
Assessor, Biopharmaceuticals at College ter Beoordeling van Geneesmiddelen - Medicines Evaluation Board (CBG-MEB)


Dr. Hoefnagel is a Senior Assessor of Biopharmaceuticals for the Medicines Evaluation Board. Since 2002 he is an assessor of the Quality of biopharmaceuticals, and specialised in cell & gene therapy products, vaccines, allergens, recombinant proteins, biosimilars. He was trained as biologist with PhD in Plant Biochemistry (Leiden University, 1993) and held several postdoc positions.

Since 2012 he contributed to the development of the substance database (GINAS/GSRS) and of the ISO-standards for biopharmaceuticals (including monoclonal antibodies, vaccine antigens, blood products, viral vectors etc.) and their capture in GSRS. He evaluated the suitability of GSRS to identify relationships between molecular structure and adverse events. Currently he is Chairman of the Substance Validation Group of the European substance database (EU-SRS) and actively advocating global use & harmonisation of GSRS.

In 2023 he was appointed as chairman of the Quality Innovation group (EMA).

Agenda Sessions

  • Global Substance Registration System (G-SRS) – expanded to Europe