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
Monitoring Plan
Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives,…
glossary
MedWatch
MedWatch is the US Food and Drug Administration’s reporting program for product complaints. MedWatch MedWatch an FDA-sponsored system for voluntarily…
glossary
Medical Device Software
A “medical device software”, refers to a computer application that meets the legal definition of a medical device and is…
glossary
Markov Model
Stochastic multi-state transition models. Transition between different states in the model are based upon pre-defined conditional probabilities that depend only…
glossary
Marketing Authorization Application (MAA)
The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks. Marketing…
glossary
Market/patient Access
Market access is the definition and achievement of a strategy aiming that all patients included in a target population will…
glossary
Market Protection
The protection of an approved medicine against competition from generic medicines that extends beyond the protection conferred by data exclusivity.…
glossary
ISO14155
International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human…
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