Our EudraVigilance support:
- Ongoing electronic reporting via EVWEB or
EVPOST - 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 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 ) andEVDAS 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
