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.

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.

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).

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.

On Friday, October 11^th 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.

The 3^rd 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.

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.

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.

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.

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.

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.

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.

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