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.