Heads on! Designing a qualification framework for Organ-on-Chip

The workshop “Heads on! Designing a qualification framework for Organ-on-Chip” was organised by the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) of the European Commission’s Joint Research Centre (JRC). It was held in Berlin in June 2023 as a pre-conference event of the Microphysiological Systems (MPS) World Summit 2023. The aim of the workshop was to collect input from stakeholders from different domains and backgrounds who are interested in the qualification of experimental methods based on Organ-on-Chip (OoC) devices for use in the pharmaceutical sector. To set the scene, ECVAM gave an introductory presentation in which the term qualification was clarified. For the purposes of the workshop, qualification was explained along the lines proposed by the European Medicines Agency i.e. an evaluation process to reach the conclusion that innovative development methods can be relied upon to have an application for a specific intended use in the context of research and development into pharmaceuticals. It was also acknowledged that although a catalogue of resources that includes existing guidance on standardisation and qualification, is already available, there is a clear need for qualification criteria specific for OoC that reflect its unique characteristics and embrace the rapid progress in the field.

PIERGIOVANNI Monica;  MENNECOZZI Milena;  SAMPANI Stavroula;  WHELAN Maurice; 

2024-05-03

SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH

JRC136708

1868-596X (online),   

https://www.altex.org/index.php/altex/article/view/2753,    https://publications.jrc.ec.europa.eu/repository/handle/JRC136708,   

10.14573/altex.2401231 (online),