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Glossary

Identified risk

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An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.

Other glossary definitions

N

New Chemical Entity (NCE)

A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and…

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E

End of Trial (EoT) Declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical…

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