Author:
Vives Joaquim,Amposta Judit
Abstract
AbstractWe live in a world of uncertainty. Moving forward in this context would be much easier if we could manage to identify, analyse, mitigate, and ultimately accept the most relevant threats, with a deep understanding of the actual significance of such risk(s). Remarkably, this strategy can be applied to any field of interest, from daily life to economics or medicine. Indeed, current quality standards in cellular therapy have already incorporated risk-based management in their guidelines. In this chapter, we present the concept of risk management as part of a quality management program and discuss by whom, why, how, and when this approach should be applied in order to benefit the production and use of safe and effective cell-based therapies in general and hematopoietic stem cell transplantation in particular.
Funder
European Society for Blood and Marrow Transplantation
Publisher
Springer International Publishing
Reference22 articles.
1. European Medicines Agency. ICH guideline Q9 on quality risk management. London; 2015.
2. Mount NM, Ward SJ, Kefalas P, Hyllner J. Cell-based therapy technology classifications and translational challenges. Philos Trans R Soc Lond Ser B Biol Sci. 2015;370(1680):20150017.
3. Vives J, Carmona G, Vives J, Carmona G. Guide to cell therapy GxP. 1st ed: Academic Press (Elsevier); 2015. 266 p.
4. Trias E, Lomas R, Tabera J, Piteira AR, Tilleman K, Casaroli-Marano RP, et al. EuroGTP II: a tool to assess risk, safety and efficacy of substances of human origin. Int J Qual Health Care. 2019;
5. Galipeau J, Sensébé L. Mesenchymal stromal cells: clinical challenges and therapeutic opportunities. Cell Stem Cell. 2018;22(6):824–33.
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