The European Affairs track at EHA2026

EHA’s European Affairs team ensures that hematologists are visible and represented in all relevant policy and regulatory discussions—from influencing upcoming EU legislation to nominating experts for the European Medicines Agency.

The European Affairs track bridges hematology clinical research and practice with the regulatory frameworks that underpin it, covering topics from clinical trials to diagnostics.

Discover our EHA2026 track below!

EHA-EMA-FDA Session on Global Trials

EHA has a strong, mutually beneficial relationship with the European Medicines Agency, frequently exchanging information and advice, and nominating hematology experts for regulatory assessments. We also participate in dedicated clinical trial initiatives including ACT EU and the Cancer Medicines Forum. EHA’s regulatory work on clinical trials has been going on for years, from advocacy on the implementation of the Clinical Trials Regulation, to founding and leading the Coalition for Reducing Bureaucracy in Clinical Trials.

The session

A8 Hall ‖ Saturday, 13 June, 13:45 – 15:15 CEST

Multi-regional clinical trials can generate evidence across populations and support timely and widespread access to innovative therapies. However, different options for trial design, conduct, and analysis as well as regional differences create challenges and uncertainties for optimizing drug development. Through short presentations and an in-depth moderated discussion, the session will discuss strategies and expectations, examine real world examples where regional differences played a critical role, and identify areas where optimal approaches could be developed.

EHA-Patient Joint Symposium

Patients are at the heart of hematology, so we systematically incorporate their perspective when developing positions on behalf of hematologists. A staple in the European Affairs track is the EHA-Patient Joint Symposium, that we organize together with EHA’s Patient Advocacy Committee. While the topics are selected by patients, they’re of interest to the broader hematology community. This annual Symposium features two multistakeholder sessions:

Session 1 — One year of EU HTA regulation: Delivering for patients and clinicians?

A8 Hall ‖ Thursday, 11 June, 13:15 – 14:45 CEST

This multistakeholder session will address key questions relating to the progress of the EU’s Health Technology Assessment Regulation, which became applicable in January 2026. How has the regulation been rolled out at national level, and what impact has it had on patients and clinicians?

Session 2 — How Patient Experience Data (PED) can inform the approval of new medicines

A8 Hall ‖ Thursday, 11 June, 15:00 – 16:30 CEST

Patient Experience Data (PED)—including patient‑reported outcomes and patient preferences—is increasingly recognized as essential to understanding whether new medicines deliver meaningful benefits for patients with hematological diseases. This session brings together perspectives from patients, clinical research and academia, industry and the EU and U.S regulatory authorities to examine how PED can be utilized across the development lifecycle.

Fertility preservation in AYA – Current challenges and future perspectives

EHA’s European Affairs department coordinates the work of the EHA AYA Taskforce, formed in 2022. The Taskforce has recently published the results of its pan-European health professional survey regarding how AYA services are defined and delivered. The survey outcomes have shaped the recently adopted EHA AYA Strategic Agenda.

The session

A12 Hall ‖ Sunday, 14 June, 09:15 – 10:45 CEST

Fertility considerations are a critical aspect of holistic care for adolescent and young adult (AYA) patients with hematological conditions. The session will cover current challenges in decision-making, clinical practice (including ovarian tissue preservation), and emerging innovations such as in vitro gamete development. Evidence for the psychological impact of fertility considerations before, during and after treatment will be discussed. The session will be contextualised with first-hand experience from an AYA patient.

Overarching SWG on diagnostics in hematology: Regulating diagnostics in Europe and impact on academia

A8 Hall ‖ Saturday, 13 June, 15:30 – 17:00 CEST

“Will I be able to diagnose hematological diseases in 3-5 years from now?” What is needed to ensure that the applicable regulatory frameworks—the EU’s In Vitro Diagnostics Regulation, but also the Clinical Trials Regulation—enable rather than obstruct innovation and patient access to essential, high-quality diagnostics? The session will look at how innovative diagnostics are regulated at the European Union level and how these rules affect hematologists.