Public invitation to tender of a computerized Adverse Event Reporting System (AERS)

10.12.2015 - Once medicinal products are on the market, they are subject to regulatory control. As part of its legal mandate, Swissmedic collects and evaluates reports of adverse drug reactions (ADRs) from primary reporters, in other words healthcare professionals (such as doctors, pharmacists and chemists), pharmaceutical companies and patients.

These ADRs are currently collected and processed in the national VigiFlow database. VigiFlow no longer meets Swissmedic's requirements in terms of a modern pharmacovigilance tool that also offers better process support and evaluation functions for business case processing. Swissmedic therefore intends to replace VigiFlow with an up-to-date Adverse Event Reporting System (AERS) that is tailed to actual requirements by the end of 2017 at the latest.

To this end, Swissmedic is seeking a supplier that can provide, in the requisite quality, a suitable standard software system plus the additional developments and services that are needed to implement this software in the Swissmedic IT architecture. The public tender according to this issue was published December 8th, 2015 on (ID No. 133597 ).