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
Reference safety information
In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the reference product information (e.g. the…
Potential risk
An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest…
Pharmacovigilance
Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
Post-market surveillance
All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a…
PMCF study
A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety…
Post-Market Clinical Follow-up (PMCF) plan
The documented, proactive, organized methods and procedures set up by the manufacturer to collect clinical data based on the use…
Periodic Summary Reporting
Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for reporting similar incidents with the…
Overdose
Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose…