Long-term follow-up of cancer patients treated with gene therapy medicinal products |
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Authors: | Galli Maria Cristina |
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Affiliation: | Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Roma, Italy. mariacristina.galli@iss. it |
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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. |
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Keywords: | cancer clinical trials follow up gene therapy |
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