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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

Pharmaceutical Establishment License (PEL)

Whilst marketing approval is granted for a given product, the company applying for marketing license…

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G

Good PharmacoVigilance Practices (GVP) for the European Union

A set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based…

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