Source: Inspectie Gezondheidszorg en Jeugd (IGJ) - Ministerie van Volksgezondheid, Welzijn en Sport
ADR Adverse Drug Reaction
AE Adverse Event
CAPA Corrective and Preventive Action; Plan van aanpak
CR Critical finding; Kritische inspectiebevinding
CRO Contract Research Organisation
EMA European Medicines Agency; Europees Geneesmiddelenbureau
GVP Good Pharmacovigilance Practices
IB Investigator’s Brochure
ICSR Individual Case Safety Report
MA Major finding; Belangrijke inspectiebevinding
MAH Marketing Authorization Holder; Handelsvergunninghouder
MI Minor finding; Overige inspectiebevinding
PAES Post-Authorisation Efficacy Study
PASS Post-Authorisation Safety Study
PhV/PV Pharmacovigilance; Farmacovigilantie/Geneesmiddelenbewaking
PIL Patient Information Leaflet; Bijsluiter
PSMF Pharmacovigilance System Master File
PSP Patient Support Program
PSUR Periodic Safety Update Report; Periodieke veiligheidsverslagen
QA Quality Assurance
QPPV Qualified Person for Pharmacovigilance; Gekwalificeerd persoon voor de geneesmiddelenbewaking
RMP Risk-Management Plan
SAE Serious Adverse Event
SAR Serious Adverse Reaction
SmPC Summary of Product Characteristics; Samenvatting van de Productkenmerken
SOP Standard Operating Procedure
SUSAR Suspected Unexpected Serious Adverse Reaction