The Regulatory Advisory Board (RAB) of EUROoCS is supporting activities in relation to the regulatory aspect of Organ-on-Chip (OoC) approaches. The RAB has worked closely together with the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) – an integral part of the European Commission’s Joint Research Centre (JRC) – on compiling a set of resources. This resource list is expected to be used as a reference point for the EUROoCS community in the development of OoC models towards their qualification and regulatory acceptance.
The catalogue incorporates two different – but interconnected – set of resources:
- a carefully selected and curated resource list of relevant reading documents (including documents, guidelines, reflection papers, guidance documents and reports published by ECHA, EFSA, EURL ECVAM, EMA, FDA, ICH and OECD), as well as other pertinent resources (peer-reviewed publications, workshop reports etc);
- a set of Frequently Asked Questions related to the main regulatory areas where OoC approaches might be of relevance (chemical, drug and food safety).
The resource list and the Frequently Asked Questions will be presented for the first time during the EUROoCS Annual Meeting (4/7/22, Session I on Qualification & Standardization) and can be found and downloaded here: