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A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.
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
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
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
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the
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