European Affairs track at the EHA2025 Congress

The work of EHA’s European Affairs team work bridges the gap between:

  • Clinical research and practice
  • The policy and regulatory realm

The team will also be doing this at the EHA2025 Congress, through a dedicated European Affairs track that involves an:

  • EHA-Patient Joint Symposium
  • EHA-EMA Joint Symposium

Both symposia will feature multistakeholder panels, exploring topics that directly affect clinicians and patients, whilst heavily depending on regulatory decision making.

The European Affairs team will also host a dedicated session about AYA (adolescents and young adults).

EHA-Patient Joint Symposium

Session 1: Advancing Quality of Life as a Measurable Outcome in Clinical Trials

June 12, 13:30–15:00 | Amber Hall 3+4

Incorporating patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) as key determinants of treatment value is crucial for driving better quality of life (QoL) outcomes.

This session will explore their integration into clinical trials and how these measures can shape treatment value evaluation.

Session 2: Evolving Endpoint Strategies: Navigating New Therapies and Regulatory Acceptance

June 12, 15:15–16:45 | Amber Hall 3+4

Developing standardized and globally accepted endpoints, including quality of life (QoL) as a co-primary endpoint, is essential for assessing the value of new drugs. This is the case in both malignant and non-malignant hematology.

This session provides a multistakeholder perspective on how endpoint strategies can evolve and better respond to patients’ lived experiences.

Both sessions will feature speaker presentations, followed by an interactive discussion with the audience.

EHA-EMA Joint Symposium

Session 1: Modernizing Tolerability Assessment and Safety Reporting

June 13, 14:00–15:30 | Amber Hall 3+4

Modernizing how adverse events and tolerability are reported and assessed is very important for patient safety. It is also crucial for improving the efficiency and quality of clinical trials and for regulatory decision making.

This session will explore whether the dual goals of advancing tolerability assessments and simplifying safety reporting can be achieved simultaneously. The discussion will be led by investigators, with key perspectives from regulators, sponsors and patients.

Session 2: Minimal Residual Disease (MRD) in clinical and regulatory decision making

June 13, 15:45–16:45 | Amber Hall 3+4

This session will delve into the nature, use, and validity of MRD as a surrogate endpoint across hematological malignancies.

The multistakeholder discussion will cover the importance of understanding MRD from the patient’s viewpoint and highlight the contrast between scientific enthusiasm and regulatory strictness. Specific cases will be used to highlight the differences in perspectives.

AYA Session: MDT considerations and perspectives on provision of AYA care

June 14, 15:45-16:45 | Amber Hall 3 + 4

This session will look at the provision of AYA care across Europe and discuss the importance of a multidisciplinary team for the care of this patient population.

Using sexual health as an example and with AYA patient advocates sharing their personal experiences, the session will provide insights on the specific needs of AYAs.