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
Company Core Safety Information (CCSI)
All relevant safety information contained in the company core data sheet prepared by the Marketing Authorization Holder and which the…
Company Core Data Sheet (CCDS)
A document prepared by the marketing authorization holder containing, in addition to safety information, material related to indications, dosing, pharmacology,…
CIOMS I Form
A form used to notify the relevant authorities of the Individual Case Safety Report (ICSR) in most countries. The form has…
Audit
A systematic, disciplined, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to…
Appropriately Reduce (risk)
The reduction of risk to an acceptable level as determined by the manufacturer and regulatory authority (reducing risk as low…
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects,…
Adverse Device Effect (ADE)
An adverse event related to the use of a medical device. This definition includes any adverse event resulting from insufficiencies…
Abnormal Use
Act or omission of an act by the operator or user of a medical device as a result of conduct…