Summary
Samenvatting Farmacovigilantie
- Course
- Institution
Dit is een samenvatting van de les van gastspreker Ceuppens over farmacovigilantie.
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Farmacovigilantie (Ceuppens)Definities
• Causality assessment
o Required for clinical investigation cases. All cases judged by either the Investigator or the
Sponsor as having a reasonable suspected causal relationship to the medicinal
product qualify as ADRs
o For purposes of reporting, AE reports associated with marketed drugs usually imply
causality
• Adverse event (AE)
o Tijdens of net na klinische studie of behandeling
o Niet noodzakelijk causaal verband met GM
o Oorzakelijkheid wordt vaak apart gerapporteerd in GCP
• Adverse drug reaction (ADR)
o Zeker dat het van het GM is (causaal verband)
• Serious AE/ADR (vanbuiten kennen!): moeten binnen 24u gerapporteerd worden en binnen
48u naar EMA etc.
o Overlijden
o Levensbedreigende bijwerking
o (Verlengde) hospitalisatie
o Blijvende of ernstige invaliditeit
o Aangeboren afwijking
o Medisch belangrijk voorval zonder hospitalisatie
• Unexpected AE/ADR
o Bijwerking waarvan aard en/of ernst niet overeenkomen met veiligheidsinformatie
over het GM
• Serious unexpected adverse reaction (SUSAR)
o Elke AE vermoedelijk gerelateerd met studiemedicatie welke zowel serious als
unexpected is
o Elke bevinding in proefdieren die een risico vormt voor humane proefpersonen
(mutageniciteit, teratogeniciteit, carcinogeniciteit)
o Bv. anafylactische shock na innemen GM, oudere mensen die plots heel verward zijn
Principes
• Signal detection: regelmatig screenen van databanken (studies, spontane reports, …)
• Stakeholders
o HCP en patiënten
o National competent authorities (NCA)
▪ PV-systeem
▪ Databank met nevenwerkingen
▪ PV-data altijd monitoren en evalueren
▪ Nagaan of MAH regels volgt → inspecties en boetes
▪ Communicatie naar patiënten en autoriteiten
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