The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

Alessandro Aiuti, Giulio Cossu, Pablo de Felipe, Maria Cristina Galli, Gopalan Narayanan, Matthias Renner, Axel Stahlbom, Christian K. Schneider, Caroline Voltz-Girolt

Research output: Contribution to journalArticlepeer-review

Abstract

In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting.

Original languageEnglish
Pages (from-to)47-54
Number of pages8
JournalHuman gene therapy. Clinical development
Volume24
Issue number2
DOIs
Publication statusPublished - Jun 2013

ASJC Scopus subject areas

  • Medicine(all)

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