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.
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What our clients say about us.
I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.
Thank you very much to you all involved recently providing the necessary additional audit documents requested by the authorities. Your support was instrumental in successfully finalizing a process that started back in February.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.