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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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Collaboration with the EMA on Joint Clinical Assessments and Joint Scientific Consultations under the HTA Regulation

The European Hematology Association (EHA) welcomes the draft Implementing Act laying down procedural rules for the exchange of information between the Health Technology Assessment (HTA) Coordination Group, the European Commission, and the European Medicines Agency (EMA).

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Transfusion

The aim of this SWG is to strengthen and invigorate European research in transfusion, to foster new networks and collaborations, with the ultimate goal of optomisingtransfusion practice in Europe based on scientific evidence.

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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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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.

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Scientific networks

Specialized Working Groups (SWGs)In order to cover the full hematology field, EHA Specialized Working Groups (SWGs) are divided in two groups: disease-oriented and overarching SWGs.

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Addressing 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.

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Membership

Boost your career, fast-track your development, and make new connections by joining a pioneering European hematology organization with global reach.

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From bedside to Brussels: hematology at the forefront of EU health policy

Access is at the heart of EHA's European Affairs work. More specifically, equitable and affordable access to innovative therapies that are of clear added benefit from a clinical, patient, and public health perspective.

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