Signalevaluation und -management mittels EudraVigilance/EVDAS
Das EViSiMa®-Projekt
europharm
Abstract
Signal evaluation and management via EudraVigilance/EVDAS
The detection and evaluation of signals is an important part of the pharmacovigilance obligations of marketing authorisation holders of medicinal products (MAHs). Since 22.11.2017 the European database for suspected adverse reactions EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) and EVDAS (EudraVigilance Data Analysis System), as tool to analyse these data, is accessible by MAHs. Therefore, a new source for the detection and evaluation of safety relevant signals is available. In EudraVigilance, the European Medicines Agency (EMA) provides statistical data derived from single cases (in the eRMRs as ROR(-) values), however, these data have to be further analysed for signal detection and for further evaluation of validated signals from sources other than EVDAS. Efficient processes are necessary to handle the great and constantly increasing amount of cases of suspected adverse reactions in EudraVigilance in accordance with regulatory obligations.
The following article provides an overview about the current regulations concerning the utilisation of the data in EudraVigilance/EVDAS. In addition, practical aspects and methods to analyse these data are explained, and challenges and limitations are discussed. This article focuses on the evaluation of validated signals in EudraVigilance/EVDAS.
Zusammenfassung
Die Detektion und Beurteilung von Signalen ist ein wichtiger Teil der Pharmakovigilanz-Verpflichtung der Zulassungsinhaber von Arzneimitteln. Seit dem 22.11.2017 steht durch die Öffnung der europäischen Datenbank für Nebenwirkungsfälle, European Union Drug Regulating Authorities Pharmacovigilance (EudraVigilance), und dem Zugang zum EudraVigilance Data Analysis System (EVDAS) für Zulassungsinhaber eine neue Quelle für die Signaldetektion und die Signalevaluierung zur Verfügung. Die Europäische Arzneimittel-Agentur (EMA) stellt über EVDAS
