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Current status of the Clinical Trials Regulation

HemAffairs Article #2 – June 2019

In 2014 the European Parliament approved the Clinical Trials Regulation (CTR) that is supposed to replace the Clinical Trials Directive (CTD) from 2001. Five years later, the regulation has not yet become applicable.

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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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Treatment of acute lymphoblastic leukemia by activation of patient's immune cells by a bispecific antibody.

 

Abstract S722
Acute lymphoblastic leukemia  (ALL) is a rare type of blood cancer which is mainly treated by intensive chemotherapy.

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EHA Issues Recommendations on Mild to Moderate Bleeding Disorders

HemaSphere presents first in a series of Consensus Reports on Diagnosis of Inherited Bleeding Problems

For hematologists, it can be challenging to make the correct diagnosis in patients with bleeding problems – or even to determine whether there is any bleeding…

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The Clot Thickens

Haemophilia B is a genetic bleeding disorder, affecting approximately 80,000 males worldwide1, caused by an insufficient or dyfunctional blood clotting protein called factor IX (FIX).

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