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
Voluntary Harmonization Procedure (VHP)
When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose…
Tissue Engineered Product (TEP)
A human tissue-engineered product (hTEP) means any autologous or allogeneic product which: contains, consists of, or results in engineered human…
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…
Substantial Amendment (SA)
A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on…
Standard of Care
Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent…
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…
Signal Detection
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety…
Serious Adverse Event (SAE)
Adverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans,…