Download pdf Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy - The JACIE Guide This open access book provides a concise yet comprehensive overview on how to build a quality management program for HSCTÂ and cellular therapy.
Download pdf EBMT receives a regulatory qualification from the European Medicine Agency (EMA) on the use of its patient registry to support novel CAR T-cell therapies. 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.
Download pdf EMA qualification opinion on Cellular therapy module of the EBMT Registry 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.
Download PDF Autologous haematopoietic stem cell transplantation and other cellular therapy in multiple sclerosis and immune-mediated neurological diseases: updated guidelines and recommendations from the EBMT Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of EBMT and ISCT (JACIE).