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
Individual Parallel Consultation
Individual Parallel Consultations are supported by the EUnetHTA ED Secretariat, thereby benefiting from HTA scientific and administrative coordination with centralised…
Individual Case Safety Report (ICSR)
An Individual Case Study Report is an adverse event report for an individual patient. Individual Case Safety Report (Synonym with…
Indication
A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.
Affordability
Affordability is the capability to allocate financial funds to an individual or societal need. Thus, we see a need to…
Adverse Drug Reaction (ADR)
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients. Adverse Drug…
Lay Person Summary (of a clinical trial)
The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format…
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…