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Glossary

Competent Authority

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Is responsible for the authorization of medicines / medical devices and for ensuring that medicines and medical devices work and are acceptably safe.

Its role is to authorize, monitor, control, inspect and inform.

Other glossary definitions

E

Ethics Committee (EC)

The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European…

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N

Non-substantial Amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does…

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