Revising the ICH Guidelines on Clinical Trials

Delegation HemAffairs

Clinical trials and drug development have become more complex over the years. One complicating factor is the increased administrative burden, as was pointed out in the previous edition of HemAffairs. Doctors and clinical researchers are more and more bound to rules they deem neither necessary nor effective. At first sight, the requirements for clinical trials seem clear and thorough. Nonetheless, the interpretation and implementation of these rules leave room for improvement.

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The past and future of the EU Blood, Tissues and Cells legislation

Annake HemAffairs HR

Blood, tissues and cells (BTC) are used in medicine and in hematology on a daily basis. EU legislation has been in place for over 15 years to regulate those practices, and to ensure safety and quality standards for substances of human origin (SoHO). For instance, through technical and traceability requirements for BTC, the reporting of serious adverse reactions (SARs), and verification procedures for imported BTC.

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

EHA delegation to ICH public meeting

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 Syn...

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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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1st joint EHA – Balkan Hematology Day, a meeting of true regional commitment

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On Friday, October 11th the European Hematology Association (EHA) co-organized with the national societies from the Balkan countries for the first joint Balkan Hematology Day. The meeting focused on lymphoid malignancies and CAR-T and the topics acute myeloid leukemia, acute lymphoblastic leukemia and CAR-T cells presented by international faculty and local clinical case presenters, resulted in a strong program with valuable messages.

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EHA-AHA Hematology Tutorial On Lymphoid Malignancies Attracts International Audi...

Armenia Tutorial report image 1

The 3rd joint Hematology Tutorial with the Armenian Hematology Association was held in October 2019, focusing this time on Lymphoid Malignancies. The meeting covered both biological and clinical aspects, giving participants the knowledge to better identify symptoms, make proper classifications and follow appropriate treatment options for each stage and age group.

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Meeting report | HOPE LA 2019 | Mendoza, Argentina

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The first edition of the Highlights of Past EHA (HOPE) meeting in Latin America (LA) was held on October 4-5, 2019 in Mendoza, Argentina. The meeting concluded the biennial congress of the Sociedad Argentina de Hematología (SAH), HOPE LA’s main partner this year.

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Meet Stefan Fröhling, our November volunteer of the month

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Professor Stefan Fröhling was first introduced to EHA in 2002 when he attended the 7th EHA Congress in Florence. He has served in a number of committees and has been an EHA Board Member (2013-2017). Currently, Professor Fröhling is a member of the EHA Scientific Working Group Unit and an Associate Editor of HemaSphere, the official journal of EHA.
Meet Stefan Fröhling and learn about what he does and why he has been volunteering for EHA for all these years.
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EHA returns to Cairo with the Highlights of the 24th EHA Congress

Cairo group photo HOPE MENA 2019

The 4th Highlights of Past EHA (HOPE) Middle East & North Africa (MENA) took place (for the third time) in Cairo, Egypt, organized in collaboration with the Pan Arab Hematology Association (PAHA) and hosted by the Egyptian Society of Hematology and Research (ESHR), and supported by the national hematology societies from the region, who were represented in the program as chairs of various sessions.

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EHA’s Prof Jäger elected HCPWP co-chair

HCPWP co chairs Prof. Ulrich Jaeger EHA and Juan Garcia Burgos EMA

On September 24, Prof Ulrich Jäger, former EHA President and current member of the EHA European Affairs Committee, was elected as co-chair of the Health Care Professionals Working Party (HCPWP) of the European Medicines Agency (EMA). He will lead the working party during its 2019-2022 mandate alongside Juan Garcia-Burgos, EMA’s head of Public Engagement.

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Without access to treatment, can we truly innovate in rare diseases?

HemAffairs Sept 24 v2

There have been many developments on rare diseases since the EU Orphan Medicinal Products Regulation came into force in 2000. As the European Commission is evaluating its effectiveness, EHA discussed with Prof. Giampaolo Merlini, Director of the Amyloidosis Research and Treatment Center and researcher at the Department of Molecular Medicine of the University of Pavia, how far we have come and what still needs to be done to improve access to treatment for rare diseases.

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COST Action ‘EuNet-INNOCHRON’

HemAffairs Oct 3

The European Cooperation in Science and Technology (COST) is an EU-funded, intergovernmental framework that aims to create pan-European research networks in all science fields and promote excellence, foster interdisciplinary research and empower young researchers and innovators.

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Open Access: the ‘Plan S’

HemAffairs Sept 24 v3

Research and academic groundwork funded with public means should be free and open to everyone. That is the principle behind Open Access that was formulated in 2003 in the Berlin Declaration. More than a decade has passed since and for years no significant action was taken. Scientific research, paid for by the taxpayer, is still mostly locked behind paywalls.

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EHA Issues Recommendations on Mild to Moderate Bleeding Disorders

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HemaSphere presents first in a series of Consensus Reports on Diagnosis of Inherited Bleeding Problems

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Meet Irene Roberts, our September volunteer of the month

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Professor Irene Roberts started volunteering for EHA in 2003 and shortly afterwards was elected as a member of the EHA Board and then the Executive Board. She held many positions on various committees and currently Professor Roberts is a member of the EHA Global Outreach Program Committee. Meet Professor Roberts and learn about what she does and why she has been volunteering for EHA for all these years.
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