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Glossary

Serious (Public) Health Threat

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Any event type, which results in an imminent risk to the study population of death, serious injury, or serious illness that requires prompt remedial action and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time. 

Other glossary definitions

P

Paediatric Investigation Plan (PIP)

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary…

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A

Abnormal Use

Act or omission of an act by the operator or user of a medical device…

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