EPTRI is actively participating in the HMA/EMA AI and Data Forum 2026: Build trustworthy AI on strong data foundations, held on 12 and 13 of November at the EMA building in Amsterdam.
The workshop, organised by the European Medicines Regulatory Network (The Network) brings together regulators and stakeholders to share progress, exchange insights, and shape the future of data and AI in medicines development and regulation. The main goals of the workshop are to:
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Showcase state-of-the-art AI and data applications across the medicines’ lifecycle,
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Discuss the evolving EU regulatory landscape for data and AI,
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Hear from stakeholders on data foundations, governance, quality, and interoperability across the Network,
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Strengthen stakeholder collaboration to accelerate the adoption of trustworthy AI,
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Input to the Network Data Steering Group (NDSG) workplan in alignment with the Network Strategy to 2028.
The two days event is structured in 6 sessions dedicated to the use of high-quality data, interoperability and the use of AI in regulation and clinical studies.
EPTRI will participate on session 4: AI in clinical trials: practical applications and future guidance needs that will examine use cases of the AI use in clinical studies.
Dr. Donato Bonifazi, Chair of TEDDY Network, and Dr. Daniel Weiss, a computer scientist at LMU Klinikum in Munich, will present AMIGO, a proposal that builds on collaboration within EPTRI, where both serve on the Board of Directors. AMIGO explores how federated AI could support molecular diagnosis and patient stratification in paediatric clinical trials.
Dr. Rafał Bartczuk, who coordinates activities within EPTRI’s Paediatric Health Data Platform, and Dr. Marek Migdal, EPTRI’s Treasurer, are both based at the Children’s Memorial Health Institute in Warsaw, an EPTRI member. They will present results from the EPISTOP project related to the use of an AI-based trial management platform and the use of AI for epilepsy prevention and early treatment.
EPTRI’s participation in the Forum reflects its commitment to helping research teams prepare, analyse and reuse paediatric health data to support research and clinical trials. Its Paediatric Health Data Platform offers a range of services, including Federated Learning and AI Applications for Clinical Settings, which can help researchers analyse data across centres while each institution retains control of its own data.
If you need support working with paediatric health data, visit our Paediatric Research Services page to explore how EPTRI’s Paediatric Health Data Platform can support your research and submit a service request.
If you wish to join EPTRI and its Paediatric Health Data Platform as a service provider, reach out to us through [email protected].
You can find more information on the HMA/EMA AI and Data Forum 2026 here. The event will live streamed here.