Long-term follow-up of cancer patients treated with gene therapy medicinal products

Authors


M. C. Galli, Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Viale Regina Elena, 299-Roma, 00161-Italy.

E-mail: 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. Copyright © 2012 John Wiley & Sons, Ltd.

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