The EUROoC validation workshop took place virtually from 17 to 19 January 2002. The focus of the workshop was to provide insights into the structure and functions of the main European regulatory agencies like Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bundesinstitut für Risikobewertung (BfR), Rijksinstituut voor Volksgezondheid en Milieu (RIVM) and Medicines Evaluation Board (CBG-MEB).
The ESRs learnt about the processes for the assessment of human medicinal products, chemicals and oncology products within the European regulatory network. Particular importance was given to the aspects of drug metabolism and drug-drug interaction when investigating compounds. Moreover, they were offered an overview of the validation processes for in-vitro models, animal models and examples of validation of microphysiological systems.
The workshop was concluded with the validation procedure for vaccines and an intro to the Inno4Vac project which has the objective to validate organ-on-chip models for the testing of vaccines at the early developmental stage, a very relevant topic of today.