VOEGELIN system engineering has been nominated by a national health authority to manage and implement the project for a B2B Gateway (IBM DataPower XB-62) with the Vigiflow™ PV-System of UMC.  This gateway will be used for the electronic submission of E2B Files between the health authority and the marketing authorization holders. The project consists of three phases:

  • Design and implementation of  a communication interface in Vigiflow™.
  • Implementation of a  B2B-Gateway for automatic E2B exchange.
  • Desgn and implementation of  a Web-based case data entry system in order to load manually entered ADR’s automatically into Vigiflow™ via E2B.

The European Medicines Agency (EMA) and other therapeutic products agencies in Australia, the USA and Singapore (TGA, FDA, HSA) currently accept reports of suspected adverse events of pharmaceuticals (individual case safety reports – ICSRs) electronically for direct processing in their databases.

The national health authority has now launched a project in a bid to implement this international standard in the automatic electronic exchange of ICSRs between the authority and the licence holders. The quality assurance requirements when exchanging ICSRs should in particular be met by means of a gateway.

The project involves the development and implementation of a gateway for exchanging (sending and receiving) ICSRs electronically in E2B format along with an electronic acknowledgement that the reports have been received (ACK-log).

Within the scope of this project, the test and pilot phases are being carried out in collaboration with pharmaceutical companies involved in the Pharmacovigilance Interassociation Working Group and guidelines are being drafted for the therapeutic products industry.

It will probably be possible to start exchanging ICSRs electronically by spring 2013.