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.

VOEGELIN system engineering has been nominated to lead the  analysis and design activities of  an new ERP system for sonic emotion. This new system should support and facilitate the business processes of marketing and sales.

Sonic emotion 3D audio technologies redefine the art of surround listening – for the first time enabling listeners to experience a natural 3D sound image from ANY input format (even stereo), using a single device!

Unlike conventional surround sound, sonic emotion technologies use wave field synthesis to create a field of sonic waves resulting in the illusion of sounds originating from all around. Listeners are surrounded in immersive, balanced audio regardless of their positioning, device location, and room dimensions. Thanks to the all-enveloping sonic waves listeners don’t hear sounds from speakers, in fact they won’t even notice where the device is! Say goodbye to small calibrated listening zones, messy cables and speaker setups. Say hello to the next generation of 3D listening with sonic emotion audio technologies.

Go-life with the successfully upgraded Argus safety™ 4.2 system at Helsinn Pharmaceuticals. VOEGELIN system engineering was responsible for all server installations, technical application upgrades as well as for the necessary validation documentation.

The project has been accomplished within timeline and budget.

Successful upgrade to MedDRA 13.0 on Argus safety™ 4.1 and automatic recoding of all existing case data to the new MedDRA version for a international pharmaceutical company.

Successful productive go-live of the automatic CIOMS to E2B conversion application.  This project was offered at a fix-price and has been implemented within time and budget specifications.

Download and read case study:  How to migrate CIOMS to E2B

Successful implementation and go-live of vaccine product & license data  configuration into Novartis Argus safety™ 4.2 drug safety system. The project has been completed in time and budget.

VOEGELIN system engineering has provided the product & license configuration framework to automate almost all configuration tasks for this project.

Successful installation of MedDRA 12 on Argus safety™ 4.1 and automatic recoding of all existing case data to the new MedDRA version for a international pharmaceutical company.