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

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

dc.contributor.author	Aiuti, Alessandro
dc.contributor.author	Cossu, Giulio
dc.contributor.author	de Felipe, Pablo
dc.contributor.author	Galli, Maria Cristina
dc.contributor.author	Narayanan, Gopalan
dc.contributor.author	Renner, Matthias
dc.contributor.author	Stahlbom, Axel
dc.contributor.author	Schneider, Christian K
dc.contributor.author	Voltz-Girolt, Caroline
dc.date.accessioned	2014-01-17T15:08:37Z
dc.date.available	2014-01-17T15:08:37Z
dc.date.issued	2013-06
dc.identifier.citation	The 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 Dev	en
dc.identifier.issn	2324-8645
dc.identifier.pmid	23862696
dc.identifier.doi	10.1089/humc.2013.119
dc.identifier.uri	http://hdl.handle.net/10033/311529
dc.description.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.
dc.language.iso	en	en
dc.rights	Archived with thanks to Human gene therapy. Clinical development	en
dc.subject.mesh	Animals	en
dc.subject.mesh	Cell- and Tissue-Based Therapy	en
dc.subject.mesh	Clinical Trials as Topic	en
dc.subject.mesh	European Union	en
dc.subject.mesh	Genetic Therapy	en
dc.subject.mesh	Genetic Vectors	en
dc.subject.mesh	Humans	en
dc.subject.mesh	Leukemia	en
dc.subject.mesh	Mice	en
dc.subject.mesh	Mutagenesis, Insertional	en
dc.subject.mesh	Risk Factors	en
dc.subject.mesh	Tissue Engineering	en
dc.subject.mesh	Transgenes	en
dc.title	The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.	en
dc.type	Article	en
dc.identifier.journal	Human gene therapy. Clinical development	en
refterms.dateFOA	2018-06-12T20:01:28Z
html.description.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.