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
Serious incident (MDR definition)
Any incident that directly or indirectly led, might have led or might lead to any of the following: The death…
glossary
Serious (Public) Health Threat
Any event type, which results in an imminent risk to the study population of death, serious injury, or serious illness…
glossary
Serious Adverse Device Effect (SADE)
Adverse Device Effect that has resulted in any of the consequences characteristic of a Serious Adverse Event.
glossary
Safety concern
An important identified risk, an important potential risk, or important missing information.
glossary
Risk minimization measure
Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to…
glossary
Risk-benefit balance
An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating…
glossary
Reference safety information
In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the reference product information (e.g. the…
glossary
Potential risk
An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest…
Resources 