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.

MedWatch

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

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 or studies, literature information or other data sources, there are new risks causally associated wit

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.

Cost-Effectiveness

Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.

End of Trial (EoT) Declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.

EudraCT Form

A harmonized application form is used for clinical trial applications across the European Union.

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the safety of the medicinal product or to measure the effectiveness of risk-management.

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