Regulation of advanced therapy medicinal products in Europe and the role of academia

Author:

Pearce Kim F.,Hildebrandt Martin,Greinix Hildegard,Scheding Stefan,Koehl Ulrike,Worel Nina,Apperley Jane,Edinger Matthius,Hauser Andrea,Mischak-Weissinger Eva,Dickinson Anne M.,Lowdell Mark W.

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics(clinical),Oncology,Immunology,Immunology and Allergy

Reference11 articles.

1. Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004. Official Journal of the European Union. 2007;L 324:121–131.

2. Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive;Maciulaitis;Mol Ther,2012

3. Manufacture of advanced therapies: academia meets industry;Sethe;Regulatory Rapporteur,2011

4. Elements of Sampling Theory;Barnett,1974

5. Multiple correspondence analysis;Abdi,2007

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