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The HARMONY project: learning to work in BIG (DATA) teams

The HARMONY project: learning to work in BIG (DATA) teams

By Anna Kabanova PhD, YoungEHA committee member

On 26 and 27 September 2019 several YoungEHA members, including myself, had the chance to participate in the 4th General Assembly of the HARMONY Alliance…

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EMA Issues Call for Expressions of Interest for Drug Safety Studies

The purpose of this call is to enable the EMA to obtain fast and reliable answers to questions on safety or benefit/risk concerns, and ultimately facilitating regulatory decision-making.

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Highlights from the SWG

Standards for functional precision medicine projectStandards for functional precision medicine, a project initiated by EHA's SWG on Precision Hematology, received a 2023 SWG Grant and is currently underway.

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Revising the ICH Guidelines on Clinical Trials

The EHA delegation to the ICH meeting: from left to right, Professors Christian Gisselbrecht, Steven Le Gouill and Martin Dreyling. Clinical trials and drug development have become more complex over the years.

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Current status of the Clinical Trials Regulation

HemAffairs Article #2 – June 2019

In 2014 the European Parliament approved the Clinical Trials Regulation (CTR) that is supposed to replace the Clinical Trials Directive (CTD) from 2001. Five years later, the regulation has not yet become applicable.

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The Clot Thickens

Haemophilia B is a genetic bleeding disorder, affecting approximately 80,000 males worldwide1, caused by an insufficient or dyfunctional blood clotting protein called factor IX (FIX).

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