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ATMPs and CAR-T: the uptake challenge
Advanced therapy medicinal products (ATMPs) are a game changer for improving the life of patients with severe to life-threatening diseases. In hematology, for instance, CAR T cell therapy has shown promising results in tackling different blood cancers.
Read moreEHA 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).
Read moreProposal for an EU Regulation on Clinical Trials: A joint statement from non-commercial and commercial organisations
This statement outlines the areas of agreement within the health and research communities on where the Regulation will improve the research environment. Aspects of the Regulation that could be improved to further support clinical research are also highlighted.
Read moreThe European Parliament adopts the Regulation on Substances of Human Origins (SoHO)
On April 24, the European Parliament gave its final endorsement to the regulation on Substances of Human Origin (SoHO).
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