The EBMT and the EHA announce a strategic partnership to empower Europe to become a global leader in the cellular therapy field for haematological diseases.

The Gemeinsame Bundesausschuss (G-BA) published its directions on the treatment of German patients with CAR T-cell therapies.

The LRAC and CTIWP have launched an open call for feedback and participation in workpackages (WP) - all EBMT Members as well as non members interested in CAR T therapies are invited to answer this open call until the September 1, 2019.

The EBMT registry has been qualified by EMA as a suitable platform for the collection of data for post-authorisation safety surveillance and efficacy studies.

EBMT requested qualification of the cellular therapy module of the EBMT Registry as suitable for performing pharmacoepidemiological studies for regulatory purposes, concerning CAR-T cell therapy for haematological malignancies.

The EBMT responded to the public consultation by the European Commission "Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products".

This report summarises observations made by the participants of the workshop organised by the EMA on February 9th 2018 on the use of registry data to support regulatory benefit-risk evaluations of CAR T-cell therapies and, in particular, post-authorisation follow-up.