Marcel Hoefnagel
Medicines Evaluation Board
Senior Assessor Biopharmaceuticals
Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars, immunogenicity, gene therapy and cell-based medicinal products. One of his interests is early patientacces. He was involved in organising a EMA/FDA workshop (2018) on Regulatory challenges in early access approaches for pharmaceuticals.