Concepedia

The risk-based approach to ATMP development – Generally accepted by regulators but infrequently used by companies

M. Kooijman, Peter J.K. van Meer, Christine C. Gispen‐de Wied, Ellen H.M. Moors, Marko P. Hekkert, Huub Schellekens

Regulatory Toxicology and Pharmacology · 2013 · 15 citations · 4 references

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4

Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive

Romaldas Mačiulaitis, Lucia D’Apote, Andrew Buchanan et al. · Molecular Therapy · 2012 · 96 citations · Full text

Regulatory Structures for Gene Therapy Medicinal Products in the European Union

Bettina Klug, Patrick Celis, Melanie Carr et al. · Methods in enzymology on CD-ROM/Methods in enzymology · 2012 · 23 citations

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Gene therapies need new development models

Fulvio Mavilio · Nature · 2012 · 14 citations · Full text

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On the edge of new technologies (advanced therapies, nanomedicines)

Spiros Vamvakas, Jorge Martinalbo, Ruben Pita et al. · Drug Discovery Today Technologies · 2011 · 13 citations

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