Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

Latest Glossary Definitions

Anonymization

The process of rendering data into a form which does not identify individuals and where identification is not likely to take place, for example to comply with the requirements of Policy 70. 

In Silico

Named after the silica, main component of computer parts. In silico technologies encompass a large number of approaches that may assist in the prediction of toxicity and fate of new and existing chemicals.

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose to go through the Voluntary Harmonization Procedure (VHP) as an alternative to the classical separate Clinical Trial Application to each Competent Authority.

Patient Information Leaflet (PIL)

Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally designated representative(s), shall be fully informed about the clinical trial in order to make an informed decision regarding their participation.

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.

End of Trial (EoT) declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.

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