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New EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect
On May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) came into effect, mandating stricter and more comprehensive certification and testing protocols for in vitro…
EHA welcomes European Parliament backing for SoHO legislation
EHA welcomes the European Parliament’s backing for SoHO legislation that puts patient safety and supply sustainability first.
Read moreClinical WG
Responsibilities:
Identifying the clinical data required for collection. Locating clinical trials where suitable samples will be collected or have already been collected. Involvement in the European Registry. Assessing the type of database and dataset currently available.
EHA response to the EU’s Pharma Revision
Last week, the European Affairs team finalised EHA's response to the proposed revision of the EU (European Union) Pharmaceutical Legislation. In April 2023, the European Commission published a proposed Directive and Regulation to replace the current, outdated legal framework.
Read moreAbstract submission & Awards
Abstract and Case Report submission is now closed. Abstract awardsIntroduced in 2021 and after 3 editions, we are excited to announce the 4th Emerging Investigators EHA-EBMT Joint Fellowship Awards in the Field of Cell Therapy and Immunotherapy 2024.
Read moreFDA Reports of Secondary Malignancies Following Chimeric Antigen Receptor (CAR) T Cell Therapies and Relative Risk: an EBMT-EHA-GoCART Coalition Statement
We need to bring your attention to the recent warning disseminated by the Food and Drug Administration (FDA) regarding T-cell lymphomas in patients undergoing Chimeric Antigen Receptor T-cell (CAR-T) therapy (1).
Read moreHelping to shape Europe’s clinical trials landscape: EHA selected for ACT EU advisory group
Improving the design, efficiency and effectiveness of clinical trials is the objective of the Accelerating Clinical Trials in the European Union (ACT EU) initiative.
Read moreUrgent action needed to avoid widespread shortage of in-vitro diagnostic tests
In a new statement, BioMed Alliance highlights its increasing concern about the availability of In Vitro Diagnostic (IVD) testing devices in Europe.
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