More than science: the European Affairs program at EHA2023
To develop and administer safe, innovative and effective treatments for patients with blood diseases, hematologists need an effective and enabling regulatory environment. EHA is the voice of its clinicians, diagnosticians and researchers at the European level, advocating for harmonized, efficient and proportionate EU policies and regulatory frameworks. We do so in close collaboration with our patient community and expert networks, as well as with other medical societies, industry organizations and regulatory agencies.
The ‘EU & Hematology track’ and other European Affairs activities at EHA2023 shed light on important regulatory developments and offer a platform for dialogue between hematologists, patients and other stakeholders.
European Affairs highlights at EHA2023:
- EHA-Patient Joint Symposium & PRO Guidelines session (Frankfurt, June 9)
Session 1 of the EHA-Patient Joint Symposium will focus on the comparator and design challenges in clinical trials in hematology. Session 2 addresses the need for integration of patient preferences in post-approval decision making on clinical effectiveness, cost-benefit and access. In between, a Guidelines Session has been programmed on a highly relevant topic: patient reported outcomes (PRO) in multiple myeloma clinical trials. Find more information here.
- EHA-EMA Joint Symposium (virtual, June 15)
Jointly organized with the European Medicines Agency, this virtual live session offers a short presentation on how EMA works followed by a panel discussion on data generation for regulatory purposes. The panel includes hematologists and patient advocates with regulatory experience as well as representatives of EMA, HTA and industry.
- EHA-HARMONY Alliance Session (Frankfurt, June 11)
Another session with broad stakeholder involvement and a regulatory dimension is the EHA-HARMONY Alliance session, on the Sunday in Frankfurt. Hematologists, patients, industry and EMA will give their views on the impact of Real-World Data and Real-World Evidence on research and clinical care.
- IVDR Session (virtual, June 15)
‘What can we do to protect innovative diagnostics in the face of IVDR?’ is the title of this virtual live session designed by EHA’s IVD Taskforce. A panel including laboratory hematologists, a senior German Ministry of Health representative and a regulatory scientist will discuss i.a. the need for European rare diagnostic networks, issues with genetic diagnostics for rare diseases and the position of diagnostic labs in relation to research labs.
- European Projects in Hematology (virtual, June 14)
Five European projects in which EHA is a partner will be presented by consortium leaders in this virtual live session: ASCERTAIN (cost-benefit, pricing and reimbursement models), SUPPLY (plasma supplies), TOLERATE (autoimmune diseases), GoCART and T2EVOLVE (both on T-cell therapies).
- Hematologists in regulatory affairs (AGM, Frankfurt, June 9)
The Annual General Meeting for EHA members will kick off with a short panel discussion on regulatory affairs involving EHA President Elizabeth Macintyre and Past-President Ulrich Jäger. How does EHA represent its members at the regulatory level, and why is it important for hematologists to get involved in regulatory affairs?
- Spotlight Talks (virtual, on-demand)
Two of the Spotlight Talks at EHA2023 – prerecorded in Frankfurt, made available as on-demand content on the congress platform – will focus on key European Affairs themes. Patient advocate Ananda Plate will talk about health data, and Prof. Martin Dreyling will speak about the importance of Reducing Bureaucracy in Clinical Trials, as leader of the coalition which EHA has established for this purpose.
- Collaboration Plaza (Frankfurt, June 8-11)
Located at the heart of the Exhibition at EHA2023, the Collaboration Plaza will again serve as hub and meeting point for the patient organizations (EHA PAC) and other important non-commercial EHA partners, ranging from scientific networks and EU-funded projects to the association of hematology specialist nurses HNHCP.
- EuroBloodNet (Frankfurt, June 8, for ERN members)
EHA is happy to welcome back the members of EuroBloodNet, the European Reference Network for rare hematological diseases, hosting an in-person meeting of the network at congress in Frankfurt.
For a full overview of European Affairs activities (session, talks, meetings, Collaboration Plaza), see here.
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