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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


Core reimbursement dossier

A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.

Suspected Unexpected Serious Adverse Reaction (SUSAR)

In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events

European network for Health Technology Assessment (EUnetHTA)

The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as wel

EMA HTA Parallel Scientific Advice

When developing a medicinal product, two milestones are of importance for making its path to the market: the granting of a marketing authorization from regulatory agencies and the proof of the medi

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the

Signal Detection

Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems o

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