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Glossary

Innovative Medicine

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A medicine that contains an active substance or combination of active substances that has not been authorised before.

Other glossary definitions

E

Expectedness

An Adverse Event is considered “expected” if events are symptomatically and physio-pathologically similar to those described…

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G

Good Clinical Practice (GCP)

As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording,…

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