Hello PV Aspirants and PV Professionals,
In this article we will understand some basic facts about EudraVigilance and EVDAS (EudraVigilance Data Analysis System).
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| EudraVigilance |
EudraVigilance database
EudraVigilance is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA).
The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
Purpose of EudraVigilance
EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.
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| EudraVigilance System Components |
EudraVigilance Gateway
-Secures electronic submissions within the EEA
-Enables the exchange of ICH ICSRs & acknowledgment Messages
-Provides Non-Repudiation through Message Disposition Notification (MDN)
EudraVigilance Database Management System (EVDBMS)
– It includes a fully automated safety and message processing mechanism, in accordance with ISO ICSR 27953-2:2011 and ICH E2B(R2) specifications
– The EudraVigilance Database is divided into two parts:
- The EudraVigilance Post-Authorisation Module (EVPM): For ICSRs related to spontaneous reports and reports from non-interventional studies
- The EudraVigilance Clinical Trial Module (EVCTM): For ICSRs related to reports on suspected unexpected serious adverse reactions (SUSARs) that occur in the frame of interventional studies
EVWEB Application
– EVWEB is a web application that is specifically designed for organizations that do not have a pharmacovigilance system for electronically reporting ICSRs to the relevant regulatory authority.
– Users can create and send electronic ICSRs
– EVWEB enables the receiving of safety and acknowledgement messages
EVDAS
eRMR
Users will be able to retrieve different eRMRs depending on the selected reference period. These reports will retrieve valid cases transmitted to the EVPM module only.
EVDAS Line Listing
The EVDAS line listing report provides the user with the listing of individual cases for a specific substance/s and specific MedDRA terms when appropriate. The report also provides the possibility to restrict the data to a specific period.
Active substance grouping
The ‘Active substance grouping’ EVDAS report provides the user with an overview of the active substances and medicinal products in the xEVMPD that are grouped under a specific ‘Active Substance high Level’. The report provides also the possibility to visualize the corresponding MAHs and serves MAHs in the identification of active substances of medicinal products for which they hold a marketing authorisation in the EEA.