EMA AI and Data Forum 2026: Building Trustworthy AI on Strong Data Foundations

The HMA/EMA AI and Data Forum 2026 takes place on 12 and 13 November 2026, in person at the European Medicines Agency building in Amsterdam (meeting room 1C) or online. Titled “Build trustworthy AI on strong data foundations”, the forum is coordinated by the Network Data Steering Group (NDSG) with the CHMP Methodology Working Party and the ACT EU initiative. Karl Broich (BfArM, HMA, NDSG co-chair) and Peter Arlett (EMA, NDSG co-chair) chair both days.

The organisers treat data and AI as interdependent. Good data give AI a foundation that can be scaled and trusted, and AI can unlock more value from the data behind it. The programme follows that logic: governance first, then data quality and interoperability, then AI regulation and guidance, then clinical trials and the future of regulatory work.

HMA/EMA AI and Data Forum 2026: programme at a glance

Source: EMA event page and workshop programme, HMA/EMA multistakeholder AI and Data Forum 2026 (Day 1 and Day 2 agendas).

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Day one: data foundations and AI in regulation

Day one runs on 12 November. Peter Arlett opens with welcome remarks, followed by Emer Cooke (EMA Executive Director), Karl Broich and a European Commission speaker still to be confirmed. A 20-minute patient perspective from Konstantina Boumaki (NDSG, EPF) leads into the opening keynote.

Session 1 asks why AI governance needs data governance. Alexandre Templier (independent expert, founder and chair of EURAICA) takes that question, and Markus Kalliola (TEHDAS2, SITRA, NDSG) covers findable and accessible data as the base for analytics and AI. Session 2 turns to standards. Quentin Darrasse (Roche, EFPIA) speaks on data standards and semantic interoperability, and Aimad Torqui (CBG-MEB, NDSG, ROG) on master data and data quality. Each session sets aside time for open questions and front-row comments from registered participants. The data standards work sits alongside the EMA and HMA open consultation on the EMRN Data Standards Framework.

Session 3 is designed as a high-level overview rather than a technical deep dive. Isabelle Clamou (European Commission) sets out how the rules for AI in pharma are changing, and Joerg Zinserling (BfArM, SAWP, MWP) reports on the status and outlook of AI guidance development. A talk on regulatory interaction pathways for AI across the medicines lifecycle is listed as speaker to be confirmed. The session also briefs attendees on the network’s approach to AI in medicines regulation.

Session 4 takes three or four AI use cases in clinical trials, selected from the call for abstracts to industry and academia. The organisers prioritised use cases already in real-life development or use, and those that show how model validation was performed. The outcomes will steer guidance ahead of a dedicated workshop on AI in clinical trials. Speakers cover:

• Endpoint assessment: Jeppe Manuel (Novo Nordisk, EFPIA) on AI image analysis for DEXA body scans, and Dr Marek Migdał (IPCZD, EPISTOP project) on AI in epilepsy prevention and early treatment.
• Trial management: Dr Rafał Bartczuk (IPCZD, EPISTOP project) on an AI-enhanced trial management platform.
• Trial simulation and prediction: Vidya Perera (Bayer, EFPIA) on a predictive model for trial success to inform study design and protocol development.
• Synthetic control arms and digital twins: Raja Shankar (IQVIA, ACRO) on foundation-model digital twins as synthetic control arms.
• Patient identification and enrichment: Donato Bonifazi and Daniel Weiss (TEDDY) on federated AI-assisted molecular diagnosis in paediatric trials, and Dr Giovanni Montesano (EU EYE) on identifying high-risk patients to reduce required sample sizes or study duration.

Gabriel Westman (CHMP/MWP, MPA, NDSG member) gives the network perspective. Industry’s own position on the topic is covered in AI guidance in clinical development: what industry is asking for.

Day two: trustworthy AI in action and the future of regulation

Day two starts on 13 November at 09:00 with a welcome from Karl Broich. The keynote on mega trends affecting medicines regulation is chaired by Helena Panayiotopoulou (CY MOH, EMA MB), with Magdalena Pajewska (URPL) as speaker.

Session 5 is chaired by Tobias Fellinger (MWP) and Evdokia Korakianiti (EMA). Joaquim Berenguer Jornet (EMA) gives an overview of network initiatives on AI in regulatory operations. Alison Dawson (Eli Lilly, EFPIA) draws lessons for guidance development from a GMP workshop, and Liese Barbier (EMA) covers research collaborations and priorities.

Session 6 closes the forum on how data and AI can reshape regulatory work and the drug development lifecycle. Grainne Power (HPRA) and Frank Foures (EMA) chair it. The panel includes Rico Slingerland (MEB) for the EMRN veterinary perspective, Gregorio Sambataro (European Heart Network) for patients, Yves Jacob (Sanofi, Vaccines Europe) for human-medicines industry and Charles Bagarie (Boehringer Ingelheim, Animal Health) for veterinary industry. The EMRN human-medicines speaker is still to be confirmed. The final 40 minutes go to identifying the common priorities that drive the change, and the forum ends at 12:45. For the wider EU regulatory agenda behind that discussion, see EMA’s 2025 achievements in medicines regulation.

What the forum is meant to deliver

The organisers list five aims: present state-of-the-art AI and data applications across the medicines lifecycle, discuss the evolving EU regulatory landscape for data and AI, hear stakeholders on data foundations, governance, quality and interoperability, strengthen collaboration to accelerate the adoption of trustworthy AI, and feed into the NDSG workplan in line with the Network Strategy to 2028.

Industry speakers from Roche, Novo Nordisk, Bayer, Eli Lilly, Sanofi and Boehringer Ingelheim appear in Sessions 2, 4, 5 and 6, alongside patient and academic voices. Several slots remain marked as to be confirmed, so the final programme may shift before November.