EMA consultation on draft for EBMT registry for cell therapy

The EBMT (The European Society for Blood & Marrow Transplantation) is responsible for retaining details of European patients who undergo cellular transplantation therapy (for example, transplants of bone marrow, or immune cell therapies).

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

Its draft qualification opinion is available here, and the EBMT now seeks comments on this draft.

Replies are sought by the 21th August, and contact details can be found via the above link.

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Published 26. July 2018 in News, News EU