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

The EMA AI and Data Forum takes place on 12 and 13 November 2026, hosted jointly by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). Delegates can attend in person at the EMA building in Amsterdam or join online.

The forum runs under the title “Build trustworthy AI on strong data foundations.” Karl Broich of Germany’s Federal Institute for Drugs and Medical Devices (BfArM) and Peter Arlett of the EMA co-chair both days in their role as co-chairs of the Network Data Steering Group (NDSG). The event is coordinated by the NDSG together with the Committee for Medicinal Products for Human Use (CHMP) Methodology Working Party and the Accelerating Clinical Trials in the EU (ACT EU) initiative.

The network is strengthening its use of data and artificial intelligence (AI) to support innovation, run more efficient regulatory processes, and reach better decisions for public and animal health. Organisers treat good data as the foundation for AI that can be scaled and trusted, and the forum is designed to turn that principle into a shared agenda.

EMA AI and Data Forum programme across two days

Day one, on 12 November, opens with welcome remarks from EMA Executive Director Emer Cooke and representatives of the European Commission, followed by a keynote on the patient perspective. Four sessions then run back to back: data governance and accessibility, interoperable and high-quality data, navigating AI in medicines regulation, and AI in clinical trials. Each pairs short presentations with open questions and front-row comments from registered participants.

Day two, on 13 November, starts with a keynote on the data and AI perspective, then moves to a session on trustworthy AI in action covering regulatory operations, lessons from a recent good manufacturing practice (GMP) workshop, and research collaborations. The programme closes with a session on reimagining medicines regulation, before panellists turn the NDSG workplan on data and AI into concrete next steps.

Keynote speakers and chairs

Broich and Arlett chair both days in their capacity as NDSG co-chairs. Emer Cooke, the EMA’s Executive Director, delivers opening remarks, and the European Commission contributes opening remarks and a session on the evolving regulatory landscape for AI and pharma. Many speaker slots remain marked as to be confirmed ahead of November.

Five aims for the network

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

The agenda’s emphasis on interoperability and data quality reflects the network’s position that trusted regulatory decisions depend on trusted data that can be found, understood, and governed. The forum’s outputs will steer guidance development, including a dedicated workshop on AI in clinical trials.

Source: European Medicines Agency