title: The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.
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.
authors.affiliation: Gene Therapy Working Party of the Committee for Advanced Therapies, European Medicines Agency, 7 Westferry Circus E14 4HB, London, United Kingdom. aiuti.alessandro@hsr.it
authors.forename: Alessandro
authors.initials: A
authors.lastname: Aiuti
authors.forename: Giulio
authors.initials: G
authors.lastname: Cossu
authors.forename: Pablo
authors.initials: P
authors.lastname: de Felipe
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Galli
authors.forename: Gopalan
authors.initials: G
authors.lastname: Narayanan
authors.forename: Matthias
authors.initials: M
authors.lastname: Renner
authors.forename: Axel
authors.initials: A
authors.lastname: Stahlbom
authors.forename: Christian K
authors.initials: CK
authors.lastname: Schneider
authors.forename: Caroline
authors.initials: C
authors.lastname: Voltz-Girolt
mesh_terms: D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects; D002986:Clinical Trials as Topic; D005062:European Union; D015316:Genetic Therapy / Q000009:adverse effects; D005822:Genetic Vectors / Q000235:genetics / Q000378:metabolism; D006801:Humans; D007938:Leukemia / Q000209:etiology; D051379:Mice; D016254:Mutagenesis, Insertional; D012307:Risk Factors; D023822:Tissue Engineering; D019076:Transgenes