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IVDR resources

IVD Taskforce Videos:Konstanze Döhner

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Monika Brüggemann

IVDR Sessions:

HemaSphere articles:
Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force
The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories
EU-Wide Access to…

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What to expect from European Affairs at EHA2024

European Affairs gives a voice to hematology professionals in Europe. The department ensures that the interests of EHA members are duly represented in policy, regulatory and scientific areas and networks.

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European Affairs Committee

Committee members
Elizabeth Macintyre, France (Chair)
Antonio Almeida, Portugal
Natacha Bolaños, Spain (Patient advocate)
Lorenzo Brunetti, Italy
Raffaella Colombatti, Italy
Julio Delgado, Spain
Isabelle Durand-Zaleski, France (Advisory member)
Tarec El-Galaly, Denmark
Martin Kaiser, Germany
Frank Leebeek, The Netherlands (Advisory member)
Kate Morgan, United Kingdom (Patient advocate)
Marek Mraz, Czech Republic
Kostas Stamatopoulos, Greece
AimThe…

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Burnouts: when caregivers become patients

Author: Côme Bommier (Young EHA Ambassador)
Affiliations: Hôpital St-Louis (Paris, France) & Mayo Clinic (Rochester MN, USA)

A survey will be released in September to further map burnout
among hematology professionals in Europe.

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Clinical trials

The advance of highly innovative, increasingly personalized therapies in hematology requires novel clinical trial designs and more flexible, adaptive regulatory frameworks and improved data generation to support decision making both during and after clinical studies.

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Regulation on Health Technology Assessment

The Regulation on Health Technology Assessment (HTAR) was proposed by the European Commission in 2018. It was formally adopted in December 2021 and will apply from January 2025.

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