The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.
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Authors
Aiuti, AlessandroCossu, Giulio
de Felipe, Pablo
Galli, Maria Cristina
Narayanan, Gopalan
Renner, Matthias
Stahlbom, Axel
Schneider, Christian K
Voltz-Girolt, Caroline
Issue Date
2013-06
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Show full item recordAbstract
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 DevPubMed ID
23862696Type
ArticleLanguage
enISSN
2324-8645ae974a485f413a2113503eed53cd6c53
10.1089/humc.2013.119
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