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

PV-Works (vet) submits electronic reports of animal health data to the EMEA and all EU Competent Authorities using the XML format defined by CVMP.

Assured has completed work with the FDA to deliver comprehensive electronic reporting functionality via an HL7 compliant XML schema that now forms part of the MedWatch Plus program. Please contact Assured for further details of this implementation.


PV Works

Overview

The regulations surrounding the need to submit veterinary adverse event data to Regulatory Authorities electronically have been in place for some time. However, initial take up has been relatively slow resulting in greater emphasis being placed on this requirement in the last two years. In Europe, the expectation that companies will report electronically is well established and thousands of cases are now being reported by PV-Works (vet) every year …… In parallel the FDA has implemented a major initiative (MedWatch Plus) to echo this.

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


PV-Works (vet) E-reporting functions

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


Assured Information Systems Ltd, 5 Eaton Court Road, Colmworth Business Park, Eaton Socon, St Neots, PE19 8ER, England. 
Telephone +44 (0) 1480 212223 Fax: +44 (0) 1480 216495

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Assured Information Systems
Workflow driven pharmacovigilance software