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Newsletter June 2026 | |
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Dear Subscriber, Welcome to the twelfth edition of the Real4Reg’s newsletter!
Furthermore, you’ll be able to find news about Real4Reg’s Final Symposium which will be taking place in November in Portugal and two new articles regarding the latest Patients Workshop and the XIV Consortium Meeting. At the end, you will be able to stay up to date on upcoming events. | |
Real4Reg’s Dissemination of Scientific Findings – Publications and PostersDissemination of scientific findings is one of the most important components to a research project’s success. On the one hand, it promotes the exchange of knowledge, fostering scientific progress and contributing to a deeper understanding of the topics under study. On the other hand, it is also a key determinant to the project’s visibility, ensuring that the results reach different stakeholders and have an impact on people’s daily life. Real4Reg has a well-defined dissemination strategy that, among other activities, includes the publishing of scientific articles in high impact peer-reviewed journals and the presentation of posters and talks in major international scientific conferences, meetings, and workshops regarding public health, applied regulatory science, pharmacoepidemiology, statistics, and artificial intelligence (AI), among others. The consortium truly believes in the importance of making the results as accessible as possible. Therefore, all the publications made so far and the ones that are yet to come, will always be shared in an open access format. This ensures a timely and effective dissemination among a wide range of stakeholders, such as health care professionals, regulatory and health technology assessment (HTA) experts, policy makers, health insurance specialists, academia, industry representatives, and general public. So far, Real4Reg has published three scientific articles. To find out more and read the full article, please click here.
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Partner Presentation – Data Analysis and Real World Interrogation Network (Darwin EU)IntroductionDARWIN EU is a European network created by The European Medicines Agency (EMA) and the European Medicines Regulatory Network (EMRN), in 2022. Currently, the coordination centre is the Erasmus University Medical Center Rotterdam and its role includes:
Goals and Data SourcesThe main goal is to provide real-world evidence (RWE) derived from real-world data (RWD) available in multiple databases mainly located in the European Union, to support decision-making in medicines lifecycle, regarding its use, safety, and effectiveness. The currently 52 used data sources are located in 19 different countries, for example Denmark, Finland, Germany, and Portugal, and include RWD from 477 325 000 people, with the earliest registry being in 1960. The data is extracted from different settings that include biobanks, claims, disease registries, hospitals, population registries, and general practitioners’ registries.1 AnalysisTo ensure privacy/security and control of the data, DARWIN EU adopted a federated analysis strategy which means that the data does not leave each data partner. They receive and run the code and share the results in an aggregated manner. This is only possible due to a previous mapping of all RWD present in each database to a widely used common data model - Observational Medical Outcomes Partnership (OMOP) – allowing the standardisation of the information across databases, the reproducibility of the studies in multiple countries/time points, and the results’ achievement in a timely manner.1 StudiesThe studies performed by DARWIN EU present a variety of different topics, with some of the most common ones being: disease prevalence/natural history, serious adverse events, vaccines effectiveness, prescription monitoring, medicines shortages, drug utilisation, and treatment patterns.1 These allow a deeper disease knowledge, improved pharmacovigilance support, strengthened regulatory decisions, among others.2 They can be divided into four categories: off-the-shelf, complex, very complex, and routine repeated analyses. In general, the studies take up to 6 months, but can also require several years, depending on factors such as complexity or number of involved countries. So far, DARWIN EU has completed 78 studies, for example “DARWIN EU ® - Eye disorders in women with breast cancer treated with anastrozole, letrozole or tamoxifen” (EUPAS1000000599) or “DARWIN EU ® - Drug utilisation study on Antibiotics in the ‘Reserve’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use” (EUPAS1000000664) and has ongoing another 36, such as “DARWIN EU ® - Enhanced preparedness of the DARWIN EU Network for regulatory questions in oncology – DARWIN OncoNet” (EUPAS1000000824) or “DARWIN EU ® - Background incidence rates of selected vaccine adverse events of special interest (AESIs) in Europe”(EUPAS1000000969).1 Relationship with Real4RegOne of the themes of the EMA network strategy to 2028 concerns RWD and AI, the core topics of Real4Reg. From EMA’s perspective, they can strengthen decision-making and be very useful for medicines’ authorisation and safety monitoring. However, a few challenges still remain, such as interoperability, data accessibility in timely manner, security/confidentiality, harmonisation, potential biases, and underdeveloped analytics.3 Similarly, to DARWIN EU, Real4Reg is trying to address some of these problems in order to improve regulatory and HTA decision-making which ultimately will benefit patients. References(1) https://www.darwin-eu.org/ (Accessed on 28/05/2026) (2) https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu (Accessed on 28/05/2026) (3) https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-medicines-agencies-network-strategy (Accessed on 28/05/2026) | |
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Real4Reg Final Symposium - Save the DateReal4Reg will host a Final Symposium on 3-4 November in Lisbon, Portugal (INFARMED, I.P.). This event will show the main findings of each research topic, the methodology used, and the lessons learnt throughout the past four years. In addition, keynotes about RWD-related initiatives and a patients dedicated session will also take place. The final agenda will be available shortly and the registration (free of charge) will open soon. | |
Real4Reg 2026 Patients Workshop “Real-World Data and Patients: Breaking the Ice”On 13 April the second Patients Workshop took place. The session had two presentations “RWD: Patient Perspectives and Applications in Healthcare” by Martin Russek (BfArM) and “PatientsLikeMe: A Platform for RWD Sharing and Patients Engagement” by Erlyn Macarayan (PatientsLikeMe). Afterwards, a roundtable discussion with Margarida Oliveira (INFARMED, I.P.) and Dirk De Valck (EUpALS) allowed the exchange of different perspectives on the importance of patient involvement in decision-making and benefits of sharing patients health-related data. Over 100 participants attended and even though a large portion were patients and patients’ organisations, the workshop was also relevant for pharmacists, professors or regulatory affairs and pharmacovigilance specialists.
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Real4Reg Consortium Meeting XIVOn 19-20 May Real4Reg had the second 2026 Consortium Meeting in Bonn (Germany) at BfArM (Real4Reg’s coordinator). During the first day, each work package presented an overview of the recently developed activities, the Advisory Board meeting took place, and a talk regarding “Target Trial Emulation and RCT – Anchored Expansion of Indications with RWE” was provided by Sebastian Schneeweiss. On the second day, several deep dive sessions occurred, Iftekhar Khan presented a demo version of ECLIPTICA ®, and the next steps for the remaining months of the project were defined. Apart from the insightful discussions and exchange of ideas, the meeting also contributed to the strengthening of the relationships between all members.
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Upcoming Events📅 24-26 June 2026, Madrid, Spain ENCALS Meeting 2026
📅 29-30 June 2026, Utrecht, Netherlands GetReal Institute Annual Conference 2026
📅 29 August – 2 September 2026, Milan, Italy 42nd Annual Meeting
For more information on additional events in the realms of RWE, AI, and health, please consult our Events page. | |
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RealReg is a project funded by the European Union under the Horizon Europe programme –Project No. 101095353. The consortium of ten European institutions aims to promote the use of real-world data to support regulatory decisions about medicines. For media inquiries, please contact: real4reg@infarmed.pt Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the granting authority can be held responsible for them. | |
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ImprintFederal Institute for Drugs and Medical Devices
(BfArM) Headquarters Bonn: Headquarters Cologne: Phone: +49 (0)228 99 307-0 If you don't want to receive this mailing anymore, you can unsubscribe with your email adress here: unsubscribe link. |
