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More information

For further information on electronic reporting and PV-Works please see our PDF.

E-Reporting

PV-Works includes a rich library of functions for electronic reporting (“e-reporting”) that ensure a comprehensive and efficient process for report generation, submission and receipt tracking.

Users may generate files in the correct format for each regulatory authority and submit them via the EVWeb system or via a gateway (subject to formal validation with the recipient).

You may also import cases received from regulatory authorities or partner companies in these same formats.

  • Compliant with ICH e2b, Eudravigilance (human and vet) and FDA HL7
  • Report cases individually or in batches
  • Validate case data against e-reporting rules
  • Import cases received from regulatory authorities or partners

Central to e-reporting is a database designed around the ICH E2b guidelines (for human pharmacovigilance) and the eudravigilance and FDA1932 regulation (for veterinary pharmacovigilance).