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
Prebiotic
Nonviable substance which, when administered in adequate amount, selectively promotes the growth, development and/or activity of beneficial microorganisms hosted by…
Unexpected adverse reaction
An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics
Use error
An act or omission of an act that results in a different medical device response than intended by the manufacturer…
Unanticipated Serious Adverse Device Effect (USADE)
A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not been identified in the current…
Unanticipated death or unanticipated serious injury
A death or serious injury is considered unanticipated if the condition leading to the event was not considered in a risk…
Unanticipated Adverse Device Effect (UADE)
Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a…
Trend reporting
A reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred…
Summary of product characteristics (SmPC)
Part of the marketing authorization of a medicinal product setting out the agreed position of the product as distilled during the…