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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…
Streamlining SoHO Management in EU Hospitals
The European Commission's Directorate-General for Health and Food Safety (DG SANTE) is committed to improving the management of Substances of Human Origin (SoHO) in EU hospitals.
Read moreEuropean 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…
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.
Read moreChairs and members
Chair (2024–2027)
Elizabeth Macintyre, Hôpital Necker-Enfants Malades et Université Paris, France
Vice-Chair (2024–2027)
Margarita Guenova, National Specialised Hospital for Active Treatment of Haematological Diseases, Belgium
Steering Committee (2024–2027)
Monika Brüggemann, University Hospital Kiel, Germany (ESHLO)
Francesco Buccisano, Tor Vergata University of Rome, Italy (SWG on Diagnosis…
Publications
Immune-monitoring of myelodysplastic neoplasms: Recommendations from the i4MDS consortium
Cristina A. Tentori, Lin P. Zhao, Benedetta Tinterri, Kathryn E. Strange, Katharina Zoldan, Konstantinos Dimopoulos, Xingmin Feng, Elena Riva, Benjamin Lim, Yannick Simoni, Vidhya Murthy, Madeline J.
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