The public consultation process of the EMA’s draft qualification opinion on the cellular therapy module of the EBMT registry ended on the 21st of August 2018. The public consultation leads to general and specific comments from stakeholders that will be addressed by the CHMP during the last quarter of 2018.
The purpose of the Cellular Therapy module of the EBMT Registry is to collect relevant and good quality clinical data on patients who have received CAR-T cell products as part of their treatment. Competent authorities will require manufacturers to perform long-term (15 years) follow-up of recipients which implies collecting significant amounts of clinical data. With this requirement in mind, the EBMT has been working with commercial CAR-T manufacturers to review and validate the Cell Therapy form. This form is expected to be fully implemented shortly. CAR T teams and clinical departments will be key to collecting the data on their patients, both at the time of treatment and subsequent follow-up. EBMT is fully committed to supporting centres members in this endeavour through training and guidance.
Lastly, as you may have seen, the EBMT will organise its 1st CAR-T cell workshop in Paris on the 15th and 16th of February 2019. The event aims at providing healthcare professionals with the much needed educational support and practical information to safely administer CAR-T cells to a growing number of patients, both in Europe and worldwide. More here: https://www.ebmt.org/events/1st-ebmt-car-t-cell-workshop