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The EU Directive: Quality Management System • Standard operating procedures • Training and reference manuals • Donor records • Traceability • Accurate documentation • Audit of outcome
Serious adverse events/reactions 1. Member States shall ensure that there is a system in place to report, investigate, register and transmit information about serious adverse events and reactions which may influence the quality and safety of tissues and cells and which may be attributed to the procurement, testing, processing, storage and distribution of tissues and cells, as well as any serious adverse reaction observed during or after clinical application which may be linked to the quality and safety of tissues and cells. 2. All persons or establishments using human tissues and cells regulated by <strong>this</strong> Directive shall report any relevant information to establishments engaged in the donation, procurement, testing, processing, storage and distribution of human tissues and cells in order to facilitate traceability and ensure quality and safety control. 3. The responsible person referred to in Article 17 shall ensure that the competent authority or authorities is or are notified of any serious adverse events and reactions referred to in paragraph 1 and is or are provided with a report analysing the cause and the ensuing outcome.
Page 1 and 2: Haematopoietic stem cells: implicat
Page 3 and 4: Stem cells live in bone marrow nich
Page 5 and 6: What do stem cells look like
Page 7 and 8: White cell colony CFU-GM
Page 9 and 10: Stem cell transplants in Europe HSC
Page 11 and 12: HSCT in Europe 1990-2000 Main indic
Page 13 and 14: Adult BMT Programme: St James’s H
Page 15 and 16: Survival of patients with acute mye
Page 17 and 18: Autologous stem cell harvests/cryop
Page 19: The Responsible Person The person d
Page 23 and 24: Core principle: Progenitor cell pro
Page 25 and 26: Laboratory personnel Minimum staffi
Page 28 and 29: JACIE standards and programme
Page 30 and 31: Irish Haematology Society: Summary

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