EudraVigilance Services

WHAT IS EUDRAVIGILANCE?

 

EudraVigilance is the European Union’s data collection and management system for suspected adverse reactions to medicinal products in the European Economic Area (EEA).

It covers both drugs under development and marketed products and is underpinned by the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) which contains details of all products under development or licensed within the EEA, which Sponsors and Marketing Authorisation Holders (MAHs) are required to maintain. EudraVigilance supports the detection and monitoring of safety signals and provides tools to generate reports and analyse safety data through its EudraVigilance Data Analysis System (EVDAS) interface.

Eudravigilance-services

EudraVigilance Activities


QVigilance can take on the role of Responsible Person for EudraVigilance for both clinical trial Sponsors or EudraVigilance EU QPPV Trusted Deputy (for MAHs). As responsible person/trusted deputy, we can manage all aspects of EudraVigilance registration and set-up; as well as on-going user and organisational administration.

Tailored solutions to support your EudraVigilance system:

  • QVigilance can support ongoing electronic reporting via EVWEB or EVPOST, even where generated E2B R2/R3 xmls originate from a non-QVigilance database (in-house or 3rd party) and undertake testing for EVPOST

  • Perform regular review for, and download of Individual Case Safety Reports (ICSRs) submitted to EudraVigilance by regulatory authorities and other MAHs in accordance with centralised reporting requirements, and for (ICSRs) processed by the EMA Medical Literature Monitoring (MLM) service

  • Manage the article 57 (XEVMPD) database for your products including submission of development and authorised medicinal product (DMP/AMP) information, PSMF location, MAH and QPPV contact details maintenance

  • Monitor the EudraVigilance Data Analysis System (EVDAS) to the extent of MAH access and download electronic Reaction Monitoring Reports (eRMRs) and EVDAS line listing reports for use in the detection and evaluation of safety signals and benefit-risk analysis

  • Manage the creation and maintenance of xml submissions of Annex I of the RMP via EudraLink portal

NEED SUPPORT TO SET UP YOUR EUDRAVIGILANCE SYSTEM?

Speak with our EU PV Specialist Team!

Submit an RFI