Funded by the EU

WP5: Haematopoietic Stem cells for Transplantation

This WP5 is composed of 3 independent tasks.  According to participants' expertise, meetings will be organised thematically:

1) Existing registries, practices and data collected will be reviewed (questionnaire survey, which will circulate among participants, ahead of the first meeting). The Survey results will be presented during the following meeting. A guideline for main safety issues; criteria & standard data set; IT specifications; governance for a national registry etc.  will be set in close collaboration with WMDA .  This guideline will then be disseminated to CAs and HSC donor centres.

(Proposed calendar for this part of the WP5 work)

(Proposed calendar for this part of the WP5 work)

2) Guidelines for CBB (irrespective of their status and purpose: private/public, allogeneic/autologous but aiming at HSC for Transplantation) covering all stages of Cord Blood banking will be drafted to harmonise the organisational framework for Cord Blood banking at EU level with the aim to increase safety, quality and transparency. Guidelines will include requirements for authorising/re-authorising CBB and quality and safety standards for CBB. By gathering the most appropriate items from already existing standards and from ARTHIQS consensus position on non-existing items, in close collaboration with WMDA, JACIE and FactNetcord, guidelines will guarantee a higher level of healthcare for both Donors and Recipients.

3) A Vade-mecum and a recommended curriculum for CBB inspectors shall provide them with specific and important issues of the field. Existing guidance and EU manuals (especially “operation manual for Competent Authorities for inspection of Tissues & Cells procurement and TEs”) as well as the complementary information of the 2013 DG SANCO survey will also be used as a basis of complementary information.

(Important points to focus on for this part of the WP5 work)

(Important points to focus on for this part of the WP5 work)

In the end of this work on Cord Blood, a training will be organised to disseminate the guidelines content, one inspector representative of each of the 28 Member States will be invited to attend, as planned within the ARTHIQS budget.

 

  

Paola Di Ciaccio, National Transplant Centre , Rome, Italy.
Co-leading team of the Haematopoietic Stem Cells for Transplantation section

Vanja Nikolac, Ministry of Health , Zagreb, Croatia.
Co-Leader of the Haematopoietic Stem Cells for Transplantation section

 

© 2014 ARTHIQS

ARTHIQS (Grant agreement n. 20132101557886) has received funding from the European Commission in the framework of the Health Programme. The sole responsibility lies with the author and the Consumers, Health and Food Executive Agency is not responsible of any use that may be made of the information contained here.