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
Suspected Unexpected Serious Adverse Reaction (SUSAR)
In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit…
glossary
Substantial Amendment (SA)
A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on…
glossary
Standard of Care
Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent…
glossary
Somatic-Cell Therapy medicinal Products (sCTP)
These contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended…
glossary
Signal Detection
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety…
glossary
Serious Adverse Event (SAE)
Adverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans,…
glossary
Scientific Advice
Advice given by a regulatory/ reimbursement authority to a manufacturer on appropriate tests and studies to be performed during product…
glossary
Risk Management Plan (RMP)
A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating…
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