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
Justification Table
In relation to Policy 70, to be completed by the Applicant to justify the proposed redaction of CCI.
In Silico
Named after the silica, main component of computer parts. In silico technologies encompass a large number of approaches that may…
Health Economic Model
A logical mathematical framework demonstrating the quantitative relationship between a defined set of variables (e.g. cost, effectiveness, net benefit) based…
Good Clinical Practice (GCP)
As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical…
Field Safety Corrective Action (FSCA)
A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading…
Early Dialogues Committee (EDC)
The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for…
Disease Risk-factor Reduction Claims (RDRC)
Possibly the highest level of medicine-like health claim that can be made on a non-drug product. It describes the propensity…
Case Report Form (CRF)
Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is…