Updating Finnish pharmaceutical data

FIMEA

The Finnish Medicines Agency Fimea, the supervisor of the Finnish pharmaceutical sector, wanted to modernise the register of medicinal products and marketing authorisations, which is central to its mission, to meet current needs. As a result of the reform, Fimea now has an up-to-date and easy-to-use register containing correct information on all medicines that have marketing authorisations in Finland. Solita also created a modern registry platform for Fimea, which makes the creation of new registers much easier and faster.

Fimea logo

Trust enabled agility in a demanding industry

“The reforms have enabled us to implement new systems in an agile way. The cooperation with Solita has been exceptionally smooth. The team has worked really seamlessly together, and the industry expertise of Solita’s employees has been impressive. Trust between operators has grown continuously, which has enabled agile practices in a demanding industry,” says Joonas Tuominen, Fimea’s IT Development Manager.

Results:

  • A register containing up-to-date information on Finnish medicinal products and marketing authorisations in one place.
  • A modern register platform with EU-level compatibility.
  • A clear improvement in the ease of use and efficiency compared to former registers.
  • The building of new registers in the future will require fewer resources and will be faster. The different registers also share a common operating logic.
  • Applications and related decisions can now be found in the same system.
  • Fimea gained significant agility know-how during the collaboration with Solita.

Old register required changes and modernisation

Fimea wanted a more modern, efficient and user-friendly register of medicinal products and marketing authorisations. The existing register had been introduced in the 1990s and had some clear shortcomings that needed to be addressed, and the register needed modernisation to meet the current requirements.

“The appearance and usability, as well as the volume of data we are able to enter, changed in a flash with the new Saga register. We made a huge leap from the old system to the new one,” says Sofia Lahtonen, Fimea’s System Coordinator.

The cooperation between Solita and Fimea started in late spring 2019, and the first part of the register was taken into use in autumn 2020. Saga is a demanding package that requires strong industry expertise, including knowledge of legislation. Solita has invested heavily in industry expertise and knowledge of regulations to ensure a strong contribution to the design work.

“We need a deep understanding of the health and wellbeing industry to be able figure out together with our customers how systems should be developed. In addition to domain expertise, we need user experience expertise, for example. In a large entity like Saga, we also need a good understanding of how the different changes will affect not only the features of the register, but also integration with other systems. Success has required seamless cooperation between us and Fimea – we have worked as a team, of which I am extremely pleased,” says Jukka Sillanpää, Solita’s Project Manager.

“The appearance and usability, as well as the volume of data we are able to enter, changed in a flash with the new Saga register. We made a huge leap from the old system to the new one.”Sofia Lahtonen, Fimea’s System Coordinator

Modern platform to facilitate and standardise creation of new registers

The goal with the Saga project was to create a single place where applications are submitted and decisions are received. Saga was to become an efficient register with consistent data models and processes that would guide users more clearly in all the different views. The register was to contain correct information about all medicinal products with marketing authorisations in Finland.

“Our goal was to have an easy-to-use, modern register that would give us access to a wide range of data and would integrate more easily with other systems,” says Heidi Mustalammi, Fimea’s Procedure Manager who is in charge of veterinary medicines.

In addition to the Saga reform, Fimea and Solita wanted to build a shared platform that would speed up and facilitate future register projects. The aim was to build and develop all of Fimea’s registers using the same operating logic and line of reasoning.

“The idea was that we would not always have to start from scratch. We wanted to build a technical environment with specific integrated services. This way, these features can be made available to new registers with minimum effort,” says Sillanpää from Solita.

Customised work with a high level of professionalism, trust and industry expertise

Saga is a purpose-built register with a browser-based interface.

Once the project had picked up speed, trust between the parties grew throughout the project period. Meanwhile, the way of working became more agile, which assisted in the realisation of the register that was difficult and complex, both technically and from a business perspective.

“The project was not very agile at first, but with the growth of trust and an ‘agile doctrine’, the project has switched to a more iterative and incremental approach. Such an agile working model was made possible by the strong trust between Solita and Fimea,” says Sillanpää.

 

“Our goal was to have an easy-to-use, modern register that would give us access to a wide range of data and would integrate more easily with other systems."Heidi Mustalammi, Fimea’s Procedure Manager, veterinary medicines

Final result: an easy-to-use, modern register and register platform

Different types of registers related to the pharmaceutical industry are one of the key foundation pillars of Fimea’s operations. The modern Saga and the register platform have made the use of registers clearer and more reliable. Furthermore, the creation and maintenance of new registers will require significantly fewer resources in the future.

“We always want to broadly think about the customer’s interests and look further into the future. We aim to deliver solutions that will work well into the future and enable the deployment of new services. Our understanding of the industry enables us to design solutions and, if necessary, challenge the customer when designing the solutions,” says Sillanpää.

Fimea also gained significant knowledge of the “agile doctrine” by using agile models during the implementation of the project.

“The register platform has enabled us to implement new systems in an agile way. We now have a really good foundation for development. We have already built two new registers on the platform since Saga, and more will be added next year. We have also been able to modernise other old registers now that the groundwork has been done properly,” says Tuominen from Fimea.

Solita employees receive praise for the collaboration.

“The Solita team is very knowledgeable, and we have been impressed by their industry expertise. I’m surprised at how intimately familiar the Solita team is with the industry and how much detailed knowledge they have about the processes,” says Mustalammi from Fimea.

The system has been smooth and seamless to use from the very start. “We have been praised by users of the register for how easy Saga is to use. We have not received any negative feedback; the project has been a success in every respect. Modern, effective reforms help the people in Fimea do things in an easier and smarter way in their everyday lives,” Tuominen says.