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 is the US Food and Drug Administration's reporting program for product complaints.
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
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the 2010 pharmacovigilance legislation.
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.
Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.
A harmonized application form is used for clinical trial applications across the European Union.
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.