The Legal & Regulatory Affairs Committee was established in 2017 to guide the EBMT’s interactions with national and European regulatory authorities and other bodies.
The Committee anticipates a demanding workload and is happy to receive expressions of interest in joining from other EBMT colleagues with an interest in regulatory matters.
The LRAC is supported by Eoin McGrath, the JACIE Operations Manager. Please write to firstname.lastname@example.org in relation to the committee's activities. Alternatively, telephone +34 93 453 8570.
The LRAC will build on existing relationships and play a watchdog role in terms of reporting on changes in regulations and guidelines that affect our sector.
- Contact EBMT members who are already acting in an expert capacity with the EU in order to bring their knowledge and experience into the LRAC.
- Prepare the EBMT’s contribution to the EU’s evaluation of the Tissue and Cells Directives.
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".
European Medicine Agency (EMA) releases their draft qualification opinion on the cellular therapy module of the EBMT registry for public consultation.
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.