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Glossary
With plenty of acronyms, procedures or references, the regulatory and market access
environments are sometimes perceived as daunting. Deciphering the language is the
start to finding one’s path.
A (3) | C (9) | D (2) | E (8) | F (4) | I (8) | M (3) | N (4) | O (1) | P (12) | Q (2) | R (1) | S (6) | T (1) | V (1)

Latest Glossary Articles


MedWatch

MedWatch is the US Food and Drug Administration's reporting program for product complaints.

Serious Adverse Event (SAE)

Adverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans, whether or not considered drug related.

Safety Data Exchange Agreement (SDEA)

A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product makes its way quickly and reliably back to the marketing authorisation

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products including the assess

Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal produc

Periodic Safety Update Report (PSUR)

The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time points post-authorization.

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