Assured Information Systems

Electronic Reporting to the EMA and FDA with PV-Works (vet)

Overview

PV-Works (vet) submits electronic reports of animal health data to the EMA and all EU Competent Authorities using the EUVeterinary XML format, as well as the HL7 compliant XML schema that is required by FDA CVM and is defined by VICH.

The import of compliant XML formats is also fully supported, allowing receipt of cases submitted to industry directly from European Competent Authorities. The import function is also implemented by Regulatory agencies using PV-Works (vet) upon receipt of electronic submissions from industry.

The PV-Works (vet) electronic reporting function is updated in line with regulatory changes. In addition to working closely with the FDA CVM, Assured also participates in the EMA E-reporting Implementation Group.

PV-Works Vet E-reporting functions

PV-Works (vet) offers more than the ability to export adverse event data into the appropriate format: