Agreement Signed with the State Expert Center of the Ministry of Health of Ukraine for the Pharmacovigilance System
We are pleased to announce that on January 1, 2025, the Institute for Information Systems Development and the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” (SEC MoH Ukraine) signed Contract No. 1/5-25 for system support services of the Automated Pharmacovigilance Information System (AISF).
The AISF system is designed to serve and ensure simultaneous access for the following categories of users:
- Management and personnel of the State Expert Center of the Ministry of Health of Ukraine
- Regional pharmacovigilance specialists
- Healthcare professionals with medical and pharmaceutical education from Ukrainian healthcare institutions
- Consumers and patients in Ukraine
- Pharmaceutical company personnel – marketing authorization holders (MAHs)
The AISF system has been in operation at the State Expert Center since January 2017 and ensures a high standard of data collection, storage, processing, and analysis for monitoring the safety of medicinal products authorized for use in Ukraine. This agreement strengthens the long-term commitment of iRIS Soft to enhancing pharmacovigilance processes in Ukraine through advanced digital solutions.
Other News
Development of a module to support GMP processes and pass production audits
We are pleased to announce that we have completed the development of a new software module “Register of Pharmaceutical Production Equipment and Systems DSBase-PER” to support GMP processes and production audits. The DSBase-PER module, through digitalization, improves the quality of management of accounting, operation, maintenance and repair processes of production equipment and enterprise systems, allows […]
The preparation of the electronic Common Technical Document (eCTD) format
The preparation of the electronic Common Technical Document (eCTD) format for drug registration requires pharmaceutical companies to transition from paper-based documentation to digital management, review established business processes, and reformat existing regulatory dossiers to comply with the new electronic standard. This transition leads to an increase in the number of files that make up the […]