Electronic Reporting to the EMA and FDA with PV-Works (vet)
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:
- Full processing of acknowledgment messages sent by the recipient is integrated into a tracking module within PV-Works (Vet) thus allowing customers to monitor electronic submissions and respond to any warning or failure messages
- Integration with any gateway software - Assured can recommend suitable software but does not mandate one particular brand
- Import of adverse event data received electronically, such as cases submitted to industry directly from European Competent Authorities
- Creation of XML files in a batch process generating larger submissions based upon query results. For example, this option can be used for annual submissions or larger volumes and is particularly useful to ensure that no case is overlooked
- Flexible mapping of value lists allows customers to adopt value lists that are relevant to their own business and use these for internal reports while still complying with the lists mandated for electronic reporting