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dc.contributor.authorAiuti, Alessandro
dc.contributor.authorCossu, Giulio
dc.contributor.authorde Felipe, Pablo
dc.contributor.authorGalli, Maria Cristina
dc.contributor.authorNarayanan, Gopalan
dc.contributor.authorRenner, Matthias
dc.contributor.authorStahlbom, Axel
dc.contributor.authorSchneider, Christian K
dc.contributor.authorVoltz-Girolt, Caroline
dc.date.accessioned2014-01-17T15:08:37Z
dc.date.available2014-01-17T15:08:37Z
dc.date.issued2013-06
dc.identifier.citationThe committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis. 2013, 24 (2):47-54 Hum Gene Ther Clin Deven
dc.identifier.issn2324-8645
dc.identifier.pmid23862696
dc.identifier.doi10.1089/humc.2013.119
dc.identifier.urihttp://hdl.handle.net/10033/311529
dc.description.abstractIn 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.
dc.language.isoenen
dc.rightsArchived with thanks to Human gene therapy. Clinical developmenten
dc.subject.meshAnimalsen
dc.subject.meshCell- and Tissue-Based Therapyen
dc.subject.meshClinical Trials as Topicen
dc.subject.meshEuropean Unionen
dc.subject.meshGenetic Therapyen
dc.subject.meshGenetic Vectorsen
dc.subject.meshHumansen
dc.subject.meshLeukemiaen
dc.subject.meshMiceen
dc.subject.meshMutagenesis, Insertionalen
dc.subject.meshRisk Factorsen
dc.subject.meshTissue Engineeringen
dc.subject.meshTransgenesen
dc.titleThe committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.en
dc.typeArticleen
dc.identifier.journalHuman gene therapy. Clinical developmenten
refterms.dateFOA2018-06-12T20:01:28Z
html.description.abstractIn 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.


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