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Resources for Organ-on-Chip validation and qualification - EUROoCS RAB

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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.

Contributors

Evangelos-Panagiotis Daskalopoulos; Jacqueline van Engelen; Jose Tarazona; Maurice Whelan; Monica Piergiovanni; Nathalie Delrue; Raffaella Corvi; Sofia Batista Leite; Sonja Beken; Susanne Brendler-Schwaab; Suzanne Fitzpatrick

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 (2026): Resources for Organ-on-Chip validation and qualification - EUROoCS RAB. European Commission, Joint Research Centre [Dataset] doi: 10.2905/JRC.FPSTWD0 PID: http://data.europa.eu/89h/7bcb1db5-5c7e-460b-b79e-ca5f642514a4

Keywords

EUROoCSMicroPhysiological SystemOrgan-on-Chipqualificationvalidation

Data access

List of relevant validation/qualification documents
Excel XLSX

XLSX is the default file format for Excel 2007 and later workbook used for Microsoft Excel spreadsheet which features calculation, graphing tools, pivot tables and a macro programming language. XLSX is in reality a ZIP compressed archive with a directory structure of XML text documents.
Downloadable file

A downloadable file for the dataset.

Use conditions
European Commission reuse notice

According to the European Commission reuse notice, reuse is authorised, provided the source is acknowledged. The reuse policy of the European Commission is implemented by the Decision of 12 December 2011. The general principle of reuse can be subject to conditions which may be specified in individual copyright notices. Therefore users are advised to refer to the copyright notices of the individual websites maintained under Europa and of the individual documents. Reuse is not applicable to documents subject to intellectual property rights of third parties.

Access conditions
No limitations

Anybody can directly and anonymously access the data, without being required to register or authenticate.

  • 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.

Other resources

Frequently Asked Questions on regulatory acceptance of Organ-on-Chip
PDF

PDF – Portable Document Format – is a file format developed to present documents, including text formatting and images, in a manner independent of application software, hardware and operating systems. Based on the PostScript language, each PDF file encapsulates a complete description of a fixed-layout flat document, including the text, fonts, vector graphics, raster images and other information needed to display it. PDF was standardized as an open format and does not require any royalties for its implementation.

Use conditions
European Commission reuse notice

According to the European Commission reuse notice, reuse is authorised, provided the source is acknowledged. The reuse policy of the European Commission is implemented by the Decision of 12 December 2011. The general principle of reuse can be subject to conditions which may be specified in individual copyright notices. Therefore users are advised to refer to the copyright notices of the individual websites maintained under Europa and of the individual documents. Reuse is not applicable to documents subject to intellectual property rights of third parties.

Access conditions
No limitations

Anybody can directly and anonymously access the data, without being required to register or authenticate.

  • 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.

Additional information

Published by
European Commission, Joint Research Centre
Contact email
jrc-f3-enquiries (at) ec.europa.eu
Update frequency
irregular

The event occurs at uneven intervals.

Data theme(s)
Health

dataset theme covering the domain of health which includes health conditions, diseases, treatments, healthcare services, and health policies
Science and technology

dataset theme covering the domains of science and technology, with science being the systematic pursuit of knowledge through testable explanations and predictions across natural, social, and formal disciplines, and technology encompassing the collective techniques, skills, methods, and processes used in producing goods, providing services, or achieving objectives like scientific research

Geographical name(s)
European Union
Issued date
2021-02-09
Created date
23 Jun 2022 13:31
Modified date
06 Jul 2022 10:21
Landing page
https://joint-research-centre.ec.europa.eu/eu-reference-laboratory-alternatives-animal-testing/alternative-methods-toxicity-testing/eurl-ecvam-validation-resources_en 
Dataset identifier
http://data.europa.eu/89h/7bcb1db5-5c7e-460b-b79e-ca5f642514a4
Other identifiers
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