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
Ethics Committee (EC)
The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals…
Environmental Risk Assessment (ERA)
In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal…
Environment Scanning
Identification of the stakeholders which are likely to use, benefit or assess the health tech product in development and which…
End of Trial (EoT) Declaration
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended. End of…
EMA HTA Parallel Scientific Advice
When developing a medicinal product, two milestones are of importance for making its path to the market: the granting of…
Efficacy-Effectiveness Gap
The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in…
Efficacy
The measurement of a medicine’s desired effect as compared to another healthcare intervention under ideal conditions, such as in a…
Effectiveness
The achievement of desired results under the usual circumstances of health care practice.