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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.
Substances of Human Origin (SoHO) legislation
EHA’s involvementEHA has been involved in both the evaluation and subsequent revision of the EU legislation on human blood and blood components. The evaluation of these rules, which dated back to 2002, began in 2016.
Read moreEHA in EU-funded project on voluntary plasma collection capacity in Europe
EHA to participate in an EU-funded project on “Strengthening voluntary non-remunerated plasma collection capacity in Europe” (SUPPLY)
Context: Plasma shortage
Plasma-derived medicinal products (PDMPs) are used to treat a variety of rare, chronic, and potentially life-threatening conditions including immune deficiencies, immune-mediated peripheral…
Strengthening Resilience and Fostering Collaboration: Ensuring a Transparent and Reliable Supply Chain for Plasma-Derived Products
The issue of immunoglobulin shortages and the importance of enhancing and maintaining plasma supplies have gained significant attention within the policy and regulatory landscape of the European Union.
Read moreHighlights from the SWG
Project groupsPan-European Transfusion Research infrAstructure (PETRA) projectThe European Blood Alliance has provided funding for a health science data project entitled: ‘Towards a Pan-European Transfusion Research infrAstructure (PETRA).
Read moreAddressing immunoglobulin shortages: EHA and EBA’s strategic recommendations at the EMA
In recent years, shortages of immunoglobulins (Ig) have become a growing concern in the European Union (EU). Since 2018, the European Medicines Agency (EMA)—the EU agency that evaluates and supervises medicines—has received an increasing number of shortage reports.
Read moreThe past and future of the EU Blood, Tissues and Cells legislation
Photo credit: Ineke Oostveen
Blood, tissues and cells (BTC) are used in medicine and in hematology on a daily basis.
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.
Read moreEHA-Balkan Hematology Tutorial on Lymphoid Malignancies
“EHA and the Albanian Association of Hematology have jointly decided to postpone the first EHA-Balkan Hematology Tutorial in response to a request from the Albanian government to limit all international meetings.
Read moreEHA-AHA Hematology Tutorial on Lymphoid Malignancies
Dates: October 18-20, 2019
Location: Yerevan, Armenia
Chairs: G Gaidano, S Danielyan, Y Hakobyan
2019 marks the 3rd time EHA is organizing a tutorial in collaboration with the Armenian Hematology Association (AHA), this time on “Lymphoid Malignancies”.