To promote the use of Organ-on-Chip (OoC) devices for regulatory applications, EURL ECVAM created a catalogue of resources for developers and end-users to support validation and qualification of these new technologies. The catalogue contains a curated list of relevant reading documents and a set of Frequently Asked Questions related to the main regulatory fields of interest for the OoC community (e.g. chemical, drug and food safety). These resources are developed in collaboration with the Regulatory Advisory Board (RAB) of the European Organ-on-Chip Society (EUROoCS) and will be updated accordingly.
- Maurice Whelan
How to cite
Sofia Batista Leite; Sonja Beken; Susanne Brendler-Schwaab; Corvi, Raffaella; Evangelos-Panagiotis Daskalopoulos; Nathalie Delrue; Suzanne Fitzpatrick; Monica Piergiovanni; Jose Tarazona; Jacqueline van Engelen; Whelan, Maurice (2021): Resources for Organ-on-Chip validation and qualification - EUROoCS RAB. European Commission, Joint Research Centre (JRC) [Dataset] PID: http://data.europa.eu/89h/7bcb1db5-5c7e-460b-b79e-ca5f642514a4
This document contains a curated list of reading and learning material to support the regulatory acceptance of Organ-on-Chip into different domains. It contains guidance documents, guidelines, reports and libraries issued by Agencies and Organisations worldwide (ECHA, EFSA, EMA, EURL ECVAM, FDA, ICH, OECD), but also scientific peer-reviewed papers relevant for standardisation and harmonisation. A brief description, the title and a link are provided for each document, together with a reference tag that is used in the complementary FAQs.
This living document compiles questions that are frequently asked by Organ-on-Chip (OoC) developers on the use of OoC technology for regulatory applications, structured according to the different domains. In the answers one can find reference to specific items in the list of relevant validation/qualification documents.