ºÚÁÏÍø

The Federal Agency for Medicines and Health Products (FAMHP) is a Belgian health authority that plays a central role in the Belgian medical landscape. The authority monitors the safety and quality of health products available on the market and plays a crucial role in the authorization of medicines. As such, it relies heavily on the effective internal management of its data. Poor data management can lead to delays in the evaluation of new products and errors in side effect monitoring. ºÚÁÏÍø, with its advanced technological expertise, has been an essential partner for the FAMHP in optimising its data management.

Rapid health product developments and increasing regulation meant that the FAMHP needed a robust data management solution to manage critical information effectively. The FAMHP were already using an application called MeSeA, but this solution was no longer able to meet the authority’s growing needs, hampering productivity and the efficient processing of marketing licence applications and pharmacovigilance files.

Following the re-awarding of the public tender to ºÚÁÏÍø, and leveraging the company's expertise in application maintenance, the FAMHP now benefits from a new, custom-built solution. To deliver this, ºÚÁÏÍø faced a daunting challenge: building on an existing application, MeSeA, created by a competitor. The FAMHP were already using this software for digital management of marketing authorization and pharmacovigilance files. ‘There were a huge number of complex files and some of them had very tight deadlines, so finding the most effective solution was a real challenge’, explains Grégory Godart, IT Manager at the FAMHP.

Data centralization and data warehouse

The FAMHP needed a combination of JAVA development expertise and familiarity with the world of medicines to optimise the database. They found these qualities in ºÚÁÏÍø. ‘We worked with very competent senior developers who already knew a bit about the MeSeA application. Their knowledge of the concepts made it easier to develop the new application’, says Grégory Godart.

Previously, the FAMHP had managed medicine-related data for human and veterinary use in different databases. They wanted to centralize all this data in order to manage the life cycle of medicines more effectively, and comply with national restrictions on electronic prescriptions. Another priority was data automation at the European level, where digital developments were occurring at breakneck pace. Godefroid Libambu Wolaka, Head of the IT Division at FAMHP, stresses the difficulty of keeping up with these developments: ‘We needed a more flexible tool that would make it possible to upgrade our systems quickly and within budget. ºÚÁÏÍø's developers are very familiar with our business, which made the task easier.’

Data management for medicines within the FAMHP had previously involved two separate databases using different technologies (MeSeA and E+R), resulting in duplication. As use cases expanded from the medical field to the veterinary and homeopathic fields, the use of MeSeA became increasingly complex. 

The FAMHP opted for a single tool for managing marketing authorization and pharmacovigilance files for all human, veterinary and homeopathic medicines (DTS - Dossier Tracking System). A separate tool (MPM - Medicinal Product Management) was chosen to manage the life cycle of medicines. ºÚÁÏÍø's consultants also worked closely with the FAMHP to set up a data warehouse, in order to fill a reporting gap in the old MeSeA application. This new, more powerful infrastructure ensures smoother navigation and optimal user-friendliness, considerably improving the system's overall performance. 

User-friendly and operationally efficient  

The project has contributed to greater operational efficiency within FAMHP. The project team, including specialists from both the FAMHP and ºÚÁÏÍø, organized demonstrations every three weeks to ensure maximum transparency and adaptability. ‘Teams were able to see the progress being made and provide feedback to guide the development of the IT team’, says Grégory Godart. This iterative approach made it possible to accommodate the needs and requirements of all stakeholders, including internal users, other key users and external bodies requiring data exports, such as the European Medicines Agency and the INAMI (Federal Belgian Health Insurance Body).

By putting the customer first, the team found the right solutions. The databases have been optimised, offering optimal responsiveness and a significant improvement in data quality. Users now benefit from smoother navigation, enhanced user experience and faster response times. The previous application, which is still used to consult old files, has been replaced by a high-performance, intuitive tool for any new files.

Close cooperation and ºÚÁÏÍø's expertise 

Close cooperation between the FAMHP and ºÚÁÏÍø has been key to the success of the project. As part of the FAMHP team, ºÚÁÏÍø's experienced developers helped to implement a new, more efficient application. Grégory Godart notes: ‘We particularly appreciated the dedication of business intelligence engineer Bart Bertels, who set up the data warehouse in just a few months. He showed great commitment in supporting us throughout this project. His knowledge of data warehouses and BI tools really helped us to drive the project forward.’

ºÚÁÏÍø also organized monthly follow-up meetings. Godefroid stresses the importance of this cooperation based on the customer's needs, explaining: ‘We considered the points raised during these meetings, and ºÚÁÏÍø made proposals for services and explained what was feasible. It was then up to us to decide on how to address any issues.’ ºÚÁÏÍø listened to the FAMHP's requirements and offered innovative and appropriate solutions, establishing lasting trust and cooperation between the two parties.

Grégory remembers ºÚÁÏÍø showed great flexibility: ‘Over the course of the project, we realised that we wanted to automate the tests for each release that went into production. Here too, we were able to call on ºÚÁÏÍø. Drawing from their expertise, they provided us with a tester and coordinated a team of other testers.’

Better data quality

Data quality is essential for the FAMHP, and the new application has made it possible to optimise existing databases. This has resulted in optimal responsiveness for users and smoother navigation in the application. Thanks to increased user-friendliness and faster response times, the FAMHP is better equipped to meet constantly changing regulatory requirements. 

Grégory is very happy with the outcome: ‘We have truly integrated ºÚÁÏÍø's resources into our team, but we are aware that the complexity of our work will require in-house monitoring.’ The FAMHP will continue to benefit from ºÚÁÏÍø's expertise in improving and maintaining the performance of the system. ‘FAMHP turned 17 this year, and our original activities are still evolving. This means IT must provide cutting-edge solutions on an ongoing basis. ºÚÁÏÍø is well-placed to help us do that’, Godefroid concludes.