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
Name Patient Use
Supply of a medicinal product which is excluded by a Member State from the provisions of Directive 2001/83/EC, in accordance…
glossary
Misuse of a medicinal product for illegal purposes
Misuse for illegal purposes is misuse with the additional connotation of an intention of misusing the medicinal product to cause…
glossary
Misuse of a medicinal product
Situations where the medicinal product is intentionally and inappropriately used not in accordance with the authorized product information.
glossary
Missing information
Gaps in knowledge about a medicinal product, related to safety or use in particular patient populations, which could be clinically significant.
glossary
Medication error
Any unintentional error in the prescribing, dispensing, or administration of a medicinal product while under the control of a healthcare…
glossary
Medical Device (MDR definition)
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or…
glossary
Manufacturer
The natural or legal person with responsibility for the design, manufacture, packaging, and labeling of a device before it is…
glossary
Listedness
An Adverse Event is considered “listed” if it is described in the product’s Company Core Safety Information (CCSI) or if…
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