The Quality Managers Committee (QMC) has for the last couple of months been working on the programme for the Quality Management Day in the Annual Meeting 2025. The programme is now live on the 51st Annual Meeting of the EBMT Website. As per previous years there are also MTE sessions on Monday 31st March 2025 and Tuesday 1st April 2025. We look forward to welcoming many of you there!
The QMC is additionally working on project and additional resources for the QM community.
Audit
One of the common areas for deficiencies from JACIE inspections are the Standards relating to Audit (e.g B4.8, C4.8, D4.8). Setting up and carrying out relevant and applicable audits can be challenging for both Centres and the Quality Managers. The first resource QMC developed is a Quick Guide to Audit, which was published in August 2024 and is available through the EBMT website. You will also find a dedicated MTE session during the Annual Meeting 2025.
Survey to understand the problems related to CAR-T at an operational level
Introduction of commercial ATMP products has brought new challenges for Centres using these products and Centres now regularly liaise with the industry partners. The GoCART Coalition and the QMC are collaborating on a project to understand some of these challenges through a survey to be sent to EBMT Centres early in the New Year. The results of the survey will be presented during the Quality Management Day in the Annual Meeting of the EBMT 2025 in Florence.
Risk Assessment
The project proposes a model and a procedure as a basic tool for identifying common risks in stem cell collection processes. Centres are free to use, adapt or develop the template according to their specific needs and resources. It is a flexible and practical resource to help JACIE-accredited centres improve their risk management and process reliability. The template is now finished. The procedure will be finalised soon.