Real4Reg Partners’ Participation in Key Events: a Brief Recap of 2025

As 2025 has come to an end, now is the perfect time to summarise Real4Reg’s journey throughout the year. The third project year was marked by important conference and workshop participations, spreading Real4Reg’s mission, proposed goals and obtained results.

group photo
© Pedro Moleiro/INFARMED,I.P. | Real4Reg Consortium Meeting in Lisbon, Portugal, 21-22 May 2025.

Here is a brief recap of our participation in key events over the past year:

  • 28-29 January, Helsinki, Finland – UEF participated in the 5th Nordic RWE and AI Conference and Real4Reg was presented in a session entitled “Use of RWD and AI Towards Value Based Decision Making and Healthcare”, allowing a discussion about the potential and difficulties in analysing real-world data (RWD) from health registers to generate real-world evidence (RWE).
  • 6 February, Bonn, Germany – BfArM organised and took part in the MetReal Cluster Multi-Stakeholder Workshop, presenting the progress made in Real4Reg up to this date. This event was helpful to foster dialogue and identify pathways to enhance the use of RWD in healthcare, discuss the relevance of guidance and training and the importance of patient’s voice in RWD research to ensure better outcomes for all stakeholders. Read more
  • 6 March, Jena, Germany – BfArM joined the Working Group on the Collection and Use of Secondary Data (AGENS) Methods Workshop to deliver an oral communication – “Bias After Censoring Concomitant Users of Test- and Control Medication When Investigating Long-Term Survival Outcomes”. This presentation discussed the role and showed the potential of simulation approaches to reduce bias, taking as an example the SGLT-2 inhibitors and their influence on the slower development of colorectal cancer.
  • 3-6 June, Turin, Italy – EUpALS hosted their Annual General Meeting 2025 and Real4Reg’s progress regarding the study of amyotrophic lateral sclerosis (ALS) in Use Cases 1 and 2 was communicated to 30 patients’ associations and 17 industry partners. This event allowed knowledge sharing between different stakeholders, contributing to the improvement of the quality of life of people diagnosed with ALS.
  • 2 July, Brussels, Belgium – INFARMED, I.P. participated in the conference EU Health Technology Assessment: Advent of a New Era of Collaboration. The session included different Horizon Europe-funded projects and a discussion regarding the role of health technology assessment (HTA) in boosting European Union’s competitiveness took place. Real4Reg was one of the examples and the oral communication addressed the project details, explored the goals, presented the Use Cases as a proof of concept and discussed expected impacts in HTA to multiple stakeholders, such as (HTA), regulatory, government agencies and patients’ associations.
  • 12 August, Munich, Germany – Fraunhofer delivered a presentation during the 4th Munich Center for Machine Learning (MCML) Workshop on Causal Machine Learning with the theme “Heterogeneous Treatment Effects in Survival Data: Application to Real-World-Data in the Context of Regulatory Decision-Making”.
  • 25-26 August, Washington, USA – UEF and BfArM participated in the International Society for Pharmacoepidemiology (ISPE) Annual Conference 2025. Three posters were presented, with very different topics: 1) analysis of Finnish fluoroquinolone consumption during 2010-2021 (UEF), 2) stakeholder’s views on implementing RWD in the regulatory process and 3) evaluation of the viability of complementing single-arm trails with external control arms to achieve more robust results, capable of helping regulatory decision making and HTA (BfArM).
  • 1 October, Online – Fraunhofer presented Real4Reg in the Workshop on Real-World Evidence for Post-Marketing Regulatory Decisions by Saudi Food and Drug Administration (SFDA). The presentation addressed an overview of the project, the main goals and the role of each work package in the achievement of final results.
  • 1-2 October, Utrecht, Netherlands – BfArM was present in the GetReal Conference 2025, with two poster presentations, one oral communication and one participation in a panel discussion. This event allowed the exchange of knowledge and ideas regarding external control arms, target trial emulations and aspects to be considered to meet regulatory and HTA expectations, such as data curation, bias mitigation or statistical methods.
  • 14 October, Barcelona, Spain – EUpALS participated in 40th European Organisation for Rare Diseases (EURORDIS) Round Table of Companies Workshop on Patient Experience Data as a co-moderator of a roundtable discussion. This session addressed how patient’s RWD is used in projects such as Real4Reg, which purposes they can serve and the positive outcomes that can arise in the process.
  • 7-8 November, Helsinki, Finland – UEF represented Real4Reg at the Farmasian päivät 2025 (Pharmacy Days 2025), an annual event dedicated to pharmacists in Finland, with a poster presentation regarding the Finnish oral antibiotic consumption during the time period 2010-2021.
  • 13-14 November, Jena, Germany – BfArM delivered a presentation regarding “(AI-supported) Use of Observational Data in Regulatory Research” at the 32nd GAA Annual Conference, with Real4Reg being one example of how these new approaches can be extremely important for regulatory decision-making.
  • 19-21 November, Uppsala, Sweden – UEF presented a poster in the 17th Annual Nordic Pharmacoepidemiological Network (NorPEN) Meeting, regarding the Finnish results of Use Case 4 – Effectiveness and drug repurposing: SGLT-2 Inhibitors. This poster addressed dispensing rates of this medication and its users’ characteristics, allowing an analysis of the pathological conditions for which these drugs are being used.
  • 26-28 November, Braga, Portugal – INFARMED, I.P. was present in the 22nd Portuguese Oncology Congress in the session “Data in Oncology – The Emerging Use of RWE in Oncology”. The presentation addressed a project overview, an explanation of each Use Case and the divulgation of Portuguese results in Use Case 1 – Description of Study Population: Breast Cancer, ALS, regarding the first disease.
  • 3 December, Online – BfArM participated in the GetReal Shared Learning Forum 2025 with a presentation under the topic “Regulatory Initiatives in Target Trial Emulation”, where Use Cases 3 and 4 were highlighted. In addition, it also took part in a panel discussion regarding what needs to be done to adopt and implement Target Trial Emulations. 

Up to date, 2025 has been the year with the most event participations, allowing the spread of Real4Reg’s mission, aims and results with different stakeholders. Furthermore, in 2025 we also had our X Consortium Meeting with in-person attendance in Lisbon, Portugal, facilitating collaboration between the partners and determination of the next steps. The end of this year also marked an important phase in the project, with the conclusion of its’ second grant period. In 2026, Real4Reg will enter its last year which will be filled with numerous project results and the organisation of events, including an Experts’ Workshop on 27 January (click here to register), a Patients’ Workshop in April and the Final Symposium in November, allowing knowledge sharing to boost research and innovation in RWE use in regulatory decision-making and HTA. More details regarding these activities will be shared soon, so stay tuned!