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

2.50
Hdl Handle:
http://hdl.handle.net/10033/311529
Title:
The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.
Authors:
Aiuti, Alessandro; Cossu, Giulio; de Felipe, Pablo; Galli, Maria Cristina; Narayanan, Gopalan; Renner, Matthias; Stahlbom, Axel; Schneider, Christian K; Voltz-Girolt, Caroline
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.
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
Journal:
Human gene therapy. Clinical development
Issue Date:
Jun-2013
URI:
http://hdl.handle.net/10033/311529
DOI:
10.1089/humc.2013.119
PubMed ID:
23862696
Type:
Article
Language:
en
ISSN:
2324-8645
Appears in Collections:
publications of the department of experimental infection research ([TC] EXPI)

Full metadata record

DC FieldValue Language
dc.contributor.authorAiuti, Alessandroen
dc.contributor.authorCossu, Giulioen
dc.contributor.authorde Felipe, Pabloen
dc.contributor.authorGalli, Maria Cristinaen
dc.contributor.authorNarayanan, Gopalanen
dc.contributor.authorRenner, Matthiasen
dc.contributor.authorStahlbom, Axelen
dc.contributor.authorSchneider, Christian Ken
dc.contributor.authorVoltz-Girolt, Carolineen
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.en
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

Related articles on PubMed

This item is licensed under a Creative Commons License
Creative Commons
All Items in HZI are protected by copyright, with all rights reserved, unless otherwise indicated.