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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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Highlights of the EHA-EMA Joint Symposium on RWE

The fourth EHA-EMA Joint Symposium at EHA2024 brought together investigators, regulators and patients to discuss the use of real world evidence (RWE) in the evaluation of new drugs.

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Publications

Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial
P. Sonneveld, A. Chanan-Khan, K. Weisel, A. K. Nooka, T. Masszi, M. Beksac, I. Spicka, V. Hungria, M. Munder, M.

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Position of EHA on Clinical Trials

 

The challenge
In Europe, the number of clinical trials is steadily decreasing. From 2007 to 2010, their number has decreased by some 20 percent from 5,028 to 4,193.

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Expert opinions for COVID-19 vaccination in patients with non-malignant hematologic diseases

Carlo Dufour, Helen Papadaki, Alan Warren, Colm Bradley, Cristina Mecucci, Jan Palmblad, Cornelia Zeidler, Francesca Fioredda, Sam Salek, Brigitte  Schlegelberger and Daniela Guardo, on behalf of the EHA SWG on Granulocytes and Constitutional Marrow Failure Disorders; Carlo L.

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Regulatory affairs & scientific relations

EHA’s regulatory work: European Medicines AgencyMost of EHA’s regulatory work entails collaboration with the European Medicines Agency (EMA).

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Major changes needed for patients to benefit from precision medicine

Precision medicine approaches the treatment of a disease via an individual’s genes, environment, and lifestyle.

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