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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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ASCERTAIN: EHA joins consortium aiming for better pricing and reimbursement models

November 28, 2022
EHA is a partner in the ASCERTAIN consortium which will develop models for the pricing, cost-benefit assessment, and reimbursement of innovative health technologies in Europe.

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EHA at ICH meeting: Excessive bureaucracy harms patient safety and innovation

To solicit input from a wide range of non-ICH members about the revision of ICH E8(R1), ICH held a Public Meeting on ICH E8(R1) “General Considerations for Clinical Studies” (Silver Spring, USA, October 31, 2019).

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EHA-SWG Scientific Meeting on Granulocytes and Constitutional Marrow Failure Syndromes

The second scientific meeting on EHA-SWG Scientific Meeting on Granulocytes and Constitutional Marrow Failure Disorders and Leukemia Predisposing Genes was held on October 10-12, 2019 in Prague, Czech Republic.

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FUNDING ALERT: Calls published on ATMPs, T cells and cancer research

In recent weeks, two Calls for proposals were published that offer relevant funding opportunities for hematologists:

1.

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EHA-AHA hematology tutorial on Biology and Management of Myeloid Malignancies

In 2016, a new hematology center opened in Yerevan, which offers new services, enabling professionals working there to apply theoretical knowledge and advanced approaches in everyday practice.

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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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Other COVID-19 Resources

Safety of COVID-19 vaccines – April updates

ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines

EMA recommends authorisation of COVID-19 medicine Evusheld

EMA recommends authorisation of booster doses of Comirnaty from 12 years of age

EMA recommends approval of Spikevax…

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