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Long-term follow-up of cancer patients treated with gene therapy medicinal products
Authors:Galli Maria Cristina
Affiliation:Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Roma, Italy. mariacristina.galli@iss. it
Abstract:European Union requirements are discussed for the long-term follow-up of advanced therapy medicinal products, as well as how they can be applied to cancer patients treated with gene therapy medicinal products in the context of clinical trials, as described in a specific guideline issued by Gene Therapy Working Party at the European Medicine Agency.
Keywords:cancer  clinical trials  follow up  gene therapy
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