Archive for the 'Drug safety systems' Category

Implementation of a E2B gateway for Vigiflow™

Drug safety systems, E2B Gateway, Miscellaneous, Vigiflow™ Comments Off on Implementation of a E2B gateway for Vigiflow™

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.

Upgrade Argus safety™ 4.1 to version 4.2

Argus safety™, Drug safety systems Comments Off on Upgrade Argus safety™ 4.1 to version 4.2

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.

Ares™ (Bassilichi) to Argus safety™ (Oracle) case data migration

Ares™, Drug safety systems Comments Off on Ares™ (Bassilichi) to Argus safety™ (Oracle) case data migration

Start of a legacy case migration project.The source data is stored into a Ares™ database (Bassilichi) and has to be migrated into Novartis Argus safety™ 4.2. The project consists of  these major project steps:

1. Complete legacy case data migration (E2B structure)
2. Adding additional case data to the migrated E2B case data
3. Identify and eliminate potential duplicates

This project runs in a validated environment and the go live is planned to be end of 2010.

VOEGELIN system engineering provides the migration framework to automate almost all migration and configuration tasks for this project.

MedDRA 13.0 Upgrade and case recoding

Argus safety™, Drug safety systems Comments Off on MedDRA 13.0 Upgrade and case recoding

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.

Argus safety™ 2.9x to 4.2 vaccine case data migration

Argus safety™ Comments Off on Argus safety™ 2.9x to 4.2 vaccine case data migration

Successful go-live with the migration of  52.000 vaccine cases from the Novartis Vaccine & Diagnostic Argus safety™ 2.9 database into Novartis Pharma Argus safety™ 4.2 drug safety system.

VOEGELIN system engineering has provided the case migration framework to automate almost all migration and configuration tasks for this project.

Argus safety™ 2.9x to 4.2 product and license configuration – part 2

Argus safety™, Drug safety systems Comments Off on Argus safety™ 2.9x to 4.2 product and license configuration – part 2

Successful implementation and go-live of vaccine product & license data configuration (H1N1) into Novartis Argus safety™ 4.2 drug safety system.

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

Automatic CIOMS to E2B conversion – go-live

Drug safety systems, Oracle™ Comments Off on Automatic CIOMS to E2B conversion – go-live

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

Argus safety™ 2.9x to 4.2 product and license configuration

Argus safety™, Drug safety systems Comments Off on Argus safety™ 2.9x to 4.2 product and license configuration

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.

MedDRA 12 Installation and case recoding

Argus safety™, Drug safety systems Comments Off on MedDRA 12 Installation and case recoding

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.

Argus safety™ 2.9.x to 4.2 product & license and case data migration

Argus safety™, Drug safety systems No Comments »

Start of a vaccine product & license data and legacy case migration project.The source data is stored into a Argus safety™ 2.9 database and has to be migrated into Novartis Argus safety™ 4.2. The project consists of two major project steps:

1. Configuration data (product & licence, LM_* etc) clean-up, configuration and migration
2. Complete legacy case data migration

This project runs in a validated environment and the go live is planned to be end of June 2009.

VOEGELIN system engineering provides the migration framework to automate almost all migration and configuration tasks for this project.