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
Health Economic Model
A logical mathematical framework demonstrating the quantitative relationship between a defined set of variables (e.g. cost, effectiveness, net benefit) based…
glossary
Good Clinical Practice (GCP)
As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical…
glossary
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…
glossary
Early Dialogues Committee (EDC)
The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for…
glossary
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…
glossary
Case Report Form (CRF)
Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is…
glossary
Briefing Book (or briefing materials)
Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development…
glossary
Adaptive Pathways
Adaptive pathway seeks to maximize the positive impact of new drugs on public health by balancing timely access for patients,…
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