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.

Meet the XEVMPD team:

Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Business Consultant
Peter Noes

Information technology professional with more than 13 years of experience from the pharmaceutical industry. Extensive business understanding and experience from IT projects mainly within the areas of Regulatory Operations – eSubmission (eCTD), Electronic Documents Management Systems (EDMS), Regulatory Information Management Systems (RIMS), XEVMPD and IDMP. Broad experience with project management, system administration and system implementation and with establishing and optimizing business processes within GxP areas.

Certified Veeva Vault Administrator, Computerized System Validation/GAMP5 and GDPR Foundation, Veeva