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
Comparative Effectiveness Analysis (CEA)
A systematic evaluation of the evidence on the outcomes of different drugs or other options for treating, preventing, or diagnosing…
glossary
Common Technical Document (CTD)
The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been…
glossary
Committee for Advanced Therapy (CAT)
The Committee for Advanced Therapies (CAT) is the European Medicines Agency’s (EMA) committee responsible for assessing the quality, safety and…
glossary
Commercially Confidential Information (CCI)
In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the…
glossary
Clinical Trial Application (CTA)
The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial…
glossary
Clinical Study Report (CSR)
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study. Clinical Study…
glossary
Clinical Impact
The effect that something is likely to have on the treatment of a particular group of people, or on the…
glossary
Clinical Evaluation Report (CER)
Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of…
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