XEVMPD

Pharma IT can support your XEVMPD operation:

  • Maintenance of XEVMPD data in the Article 57 database (EVWEB)
    • Creation of new XEVMPD records in connection with new marketing authorisations
    • Update of XEVMPD records in connection with changes to marketing authorisations
    • Deactivation of XEVMPD records in connection with de-registrations of marketing authorisations
    • Creation of Investigational Products records
  • Extract of XEVMPD data from EVWEB for regular completeness and correctness checks
  • Investigate and respond to XEVMPD data quality questions from EMA
  • Provide guidance and training to prepare new EVWEB users to pass EMA’s XEVMPD exam
  • Establish internal process flows to ensure that regulatory activities (new marketing authorisations, variations, de-registrations) are timely reported in EVWEB

If you need support don’t hesitate to contact us.