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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.

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Immunoglobulin shortages in the spotlight: EMA, SUPPLY and the SoHO Regulation

EMA executive director Emer Cooke welcoming participants including EHA at the Shortages Workshop, March 1

 

Shortages of immunoglobulins and the need to increase and sustain plasma supplies have moved to the center of the EU policy and regulatory stage.

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Policy & advocacy

At the core of EHA’s advocacy efforts are four priority themes. For each of these themes, the main messages and recommendations directed at EU institutions and other stakeholders have been written down in a Position Paper.

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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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IVDR

As of May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect.

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Treatment and survival of patients with chronic myeloid leukemia (CML) in Europe

Since the introduction of tyrosine kinase inhibitors into the treatment of CML survival times have greatly improved.

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Urgent 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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EU Parliament agrees on pharmaceutical legislation stance

On April 10, the European Parliament adopted its position on the revision of the EU pharmaceutical legislation.

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