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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
Aiuti, Alessandro
Cossu, Giulio
de Felipe, Pablo
Galli, Maria Cristina
Narayanan, Gopalan
Renner, Matthias
Stahlbom, Axel
Schneider, Christian K
Voltz-Girolt, Caroline
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2013-06
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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.
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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
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en
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2324-8645
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Archived with thanks to Human gene therapy. Clinical development