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Glossary

Off-label use

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Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorization. 

Other glossary definitions

C

Case Report Form (CRF)

Data collected in the frame of a clinical trial must be recorded in order to…

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Q

Qualified Person for PharmacoVigilance (QPPV)

Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.…

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