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
ISO 13485
ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen…
glossary
Investigator’s Brochure
Investigators need to be provided with information about the investigational medicinal product (IMP) data, in order to facilitate their understanding…
glossary
Investigational New Drug (IND)
Administering an investigational drug to humans is subject to prior approval from regulatory authorities. Investigational New Drug An IND is…
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Investigational Medicinal Product Dossier (IMPD)
Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided…
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Investigational Device Exemption (IDE)
Approval of an Investigational Device Exemption (IDE) submission must occur by the FDA before a manufacturer can begin a (moderate…
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International Committee for Harmonisation (ICH)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the…
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Integrated summary of Safety (ISS)
Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an…
glossary
Integrated summary of efficacy (or effectiveness) (ISE)
Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an…
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