EudraVigilance

EudraVigilance services.

Expert management of your mandatory EU safety data connections.

What is EudraVigilance?

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a data processing network and management system operated by European Medicines Agency (EMA) on behalf of the European Union (EU) medicines regulatory network.

Its scope covers drugs which are in development and existing marketed products and is supported by the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) containing details of all the development or licensed products within the EEA. 

Marketing Authorization Applicants (MAAs), Sponsors and Marketing Authorization Holders (MAHs) must be registered in the system and fully maintain a range of specific key data points.

Sponsors and MAHs can manage and submit ICSRs and SUSARs through EudraVigilance during clinical trials, the authorization period, or via data submission (art 57/ xEVMPD). The system also supports the detection and monitoring of safety signals, safety data analysis, and reporting through the EudraVigilance Data Analysis System (EVDAS) interface.

Our EudraVigilance services.

We can create and manage your EudraVigilance account, update your organization’s data as needed, create and manage your affiliates and virtual affiliates, and manage your users.

We can also help you setup your gateway transmission to connect to the EMA and perform regulatory submission of ICSRs directly, using either our own Veeva Vault Safety database or your existing safety database.

We will guide you through the whole EudraVigilance set-up process and manage the transfer of the QPPV and/ or Responsible Person functions from previous providers, as needed.

What our clients say about us.

Selected PV Case Studies.

Selected PV Case Studies.

Local PV, regulatory strategy
23 Countries in two months.
Pharmacovigilance system, Europe, Local and global PV
EU expertise delivers results.