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Review

Training Programme

Ilknur Kozanoglu  1   2 , Songul Tepebasi  3
Mahmoud Aljurf  1 , John A. Snowden  2 , Patrick Hayden  3 , Kim H. Orchard  4 , Eoin McGrath  5
, editors.
In: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: The JACIE Guide [Internet]. Cham (CH): Springer; 2021. Chapter 17.
.
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Review

Training Programme

Ilknur Kozanoglu et al.
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Excerpt

Cell therapy is a complex field, with a plethora of therapeutic procedures that widely differ among and within countries. An effective and efficient quality management (QM) system is essential to ensure the safety of patients, donors, and medical personnel, and to ensure that all aspects of the cell therapy process from product select to infusion are safe. Risk minimisation requires all personnel involved in cell therapy to be familiar with the procedures as well as cooperate with personnel from other disciplines. Staff training plays a key role in the implementation of cell therapy and in QM. New cell therapy applications are constantly being developed. Appropriate training of personnel will improve both the effectiveness of cell therapy and patient survival.

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References

    1. Commission Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. 2006. European Union.
    1. Commission Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding. 2006. Regulation. European Union.
    1. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. 2004. Regulation. European Uniion.
    1. FACT-JACIE International Standards for hematopoietic cellular therapy product collection, processing, and administration. 7th edn. 2018. FACT-JACIE.
    1. Piras A, Aresi P, Angelucci E. [Analysis of the accreditation process JACIE Transplant Program Businco]. Professioni infermieristiche. 2015;68(2):167–73. Available at: http://www.ncbi.nlm.nih.gov/pubmed/26402237. Accessed 1 Oct 2015. - PubMed

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