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
Emerging Safety Issue
A safety issue considered by a marketing authorization holder to require urgent attention by the competent authority because of the…
glossary
Direct Healthcare Professional Communication (DHPC)
A communication intervention by which important information is delivered directly to individual healthcare professionals by a marketing authorization holder or…
glossary
Device Deficiency
Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety, or performance. This may include malfunctions,…
glossary
Development safety update report (DSUR)
Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products…
glossary
Development international birth date (DIBD)
Date of first approval (or authorization) for conducting an interventional clinical trial in any country (ICH-E2F Guideline, Volume 10 of…
glossary
Data lock point (DLP)
For a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in…
glossary
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…
glossary
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,…
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