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
CIOMS I Form
A form used to notify the relevant authorities of the Individual Case Safety Report (ICSR) in most countries. The form has…
glossary
Audit
A systematic, disciplined, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to…
glossary
Appropriately Reduce (risk)
The reduction of risk to an acceptable level as determined by the manufacturer and regulatory authority (reducing risk as low…
glossary
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects,…
glossary
Adverse Device Effect (ADE)
An adverse event related to the use of a medical device. This definition includes any adverse event resulting from insufficiencies…
glossary
Abnormal Use
Act or omission of an act by the operator or user of a medical device as a result of conduct…
glossary
Voluntary Harmonization Procedure (VHP)
When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose…
glossary
Tissue Engineered Product (TEP)
A human tissue-engineered product (hTEP) means any autologous or allogeneic product which: contains, consists of, or results in engineered human…
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