The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
glossary
Pharmacovigilance
Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
glossary
Post-market surveillance
All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a…
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PMCF study
A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety…
glossary
Post-Market Clinical Follow-up (PMCF) plan
The documented, proactive, organized methods and procedures set up by the manufacturer to collect clinical data based on the use…
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Periodic Summary Reporting
Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for reporting similar incidents with the…
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Overdose
Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose…
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Off-label use
Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the terms of the…
glossary
Occupational exposure to a medicinal product
For the purpose of reporting cases of suspected adverse reactions, an exposure to a medicinal product as a result of…
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