Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?-Reference-Cited by-同舟云学术

Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

Published:2017-09 Issue:3 Volume:28 Page:126-135
ISSN:2324-8637
Container-title:Human Gene Therapy Clinical Development
language:en
Short-container-title:Human Gene Therapy Clinical Development

Author:

Boráň Tomáš¹,Menezes-Ferreira Margarida²,Reischl Ilona³,Celis Patrick⁴,Ferry Nicolas⁵,Gänsbacher Bernd⁶,Krafft Hartmut⁷,Lipucci di Paola Michele⁸,Sladowski Dariusz⁹,Salmikangas Paula¹⁰

Affiliation:

1. Státní üstav pro kontrolu léčiv, Prague, Czech Republic

2. Infarmed—National Authority of Medicines and Health Products, Lisbon, Portugal

3. Austrian Medicines and Medical Devices Agency (AGES MEA), Vienna, Austria

4. European Medicines Agency (EMA), London, United Kingdom

5. Université Paris Descartes, Paris, France

6. Institute of Experimental Oncology and Therapeutics, Technical University of Munich, Munich, Germany

7. Paul-Ehrlich Institute, Langen, Germany

8. European Organisation for Rare Diseases, Paris, France

9. Medical University of Warsaw, Department of Transplantology and Central Tissue Bank, Warsaw, Poland

10. Finnish Medicines Agency, Helsinki, Finland.

Publisher