PharmacoSoftware GmbH is developing new software to enable marketing authorization holders to fulfill all the requirements for electronic transmission to the XEVMPD (Extended EudraVigilance Medicinal Product Dictionary), thereby implementing the mandatory requirements of Article 78(2) of Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010.
The standards underlying transmission are broadly in line with the E2B requirements, and the technical criteria for electronic transmission are identical to those for the transmission of adverse reactions. We are convinced that we offer the optimum criteria for the development of software that is compatible with the EVMPD, since we have over 6 years’ experience in the electronic transmission of ICSRs.
Our experienced team of developers is already working intensively on the programming, in order to ensure on-time transmission on 2 July 2012.
This software will be capable of importing existing data from other databases. It will have a direct interface with the vigiS3®, although it may of course also be used as a standalone solution. We will also be applying the principle that has brought us many years of success with the vigiS3®:
- Access will be online
- The software will be installed on a central server
- There will be no need for validation within the company’s own IT environment
Further details will soon be appearing on this website.