Electronic Reporting with PV Works
PV-Works implements electronic reporting of drug safety data in full compliance with ICH E2B.
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OverviewThe regulations surrounding the need to submit 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. The expectation that companies will report electronically is well established…… and will increase further with the FDA's MedWatch Plus initiative. The PV-Works electronic reporting function is updated regularly in line with regulatory changes. |
PV-Works E-reporting functions
PV-Works 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.
- This allows 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 from Regulatory Authorities or Licensed Partners
- Creation of XML files in a batch process.
- This allows customers to create large submissions based upon the results of a query.
- 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.
- This 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.
- Extension of the electronic reporting model to include Licensed Partners and other third parties such as call centres
- E2B reporting formats are already supported
- The function can be extended to include third party formats
Electronic Data Import
Customers are able to import adverse event data received electronically. An example of this would be the import of cases received via a third-party Call Centre, thus reducing data entry time and costs and ensuring higher quality.
Assured Information Systems Ltd, 5 Eaton Court Road, Colmworth Business Park, Eaton Socon, St Neots, PE19 8ER, England. |
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