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Glossary

Micro-organism

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Micro-organism means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture.

 

Other glossary definitions

V

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU…

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A

Adverse Device Effect (ADE)

An adverse event related to the use of a medical device. This definition includes any…

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