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
Important Missing Information
Critical gaps in knowledge for specific safety issues or populations that use the marketed product.
glossary
Important identified risk and Important potential risk
An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have…
glossary
Identified risk
An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.
glossary
Good PharmacoVigilance Practices (GVP) for the European Union
A set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based on Article 108a of Directive…
glossary
Falsified Medicinal Product
Any medicinal product with a false representation of (a) its identity, including its packaging and labeling, its name or its…
glossary
Expectedness
An Adverse Event is considered “expected” if events are symptomatically and physio-pathologically similar to those described in the safety section of…
glossary
Expedited Criteria
Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited reporting are: an identifiable patient,…
glossary
EU Reference Date
For medicinal products containing the same active substance or the same combination of active substances, the date of the first…
Resources 