Challenges with advanced therapy medicinal products and how to meet them

Advanced therapy medicinal products (ATMPs) offer hope for the treatment of diseases for which therapeutic options are currently lacking. This article discusses the regulatory role of the Committee for Advanced Therapies at the European Medicines Agency, highlighting issues and challenges observed i...

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Veröffentlicht in:	Nature reviews. Drug discovery 2010-03, Vol.9 (3), p.195-201
Hauptverfasser:	Schneider, Christian K, Salmikangas, Paula, Jilma, Bernd, Flamion, Bruno, Todorova, Lyubina Racheva, Paphitou, Anna, Haunerova, Ivana, Maimets, Toivo, Trouvin, Jean-Hugues, Flory, Egbert, Tsiftsoglou, Asterios, Sarkadi, Balázs, Gudmundsson, Kolbeinn, O'Donovan, Maura, Migliaccio, Giovanni, Ancāns, Jānis, Maciulaitis, Romaldas, Robert, Jean-Louis, Samuel, Anthony, Ovelgönne, Johannes H, Hystad, Marit, Fal, Andrzej Mariusz, Lima, Beatriz Silva, Moraru, Anca Stela, Turcáni, Peter, Zorec, Robert, Ruiz, Sol, Akerblom, Lennart, Narayanan, Gopalan, Kent, Alastair, Bignami, Fabrizia, Dickson, J George, Niederwieser, Dietger, Figuerola-Santos, María-Angeles, Reischl, Ilona G, Beuneu, Claire, Georgiev, Rosen, Vassiliou, Maria, Pychova, Alena, Clausen, Mette, Methuen, Taina, Lucas, Sophie, Schüssler-Lenz, Martina, Kokkas, Vasilios, Buzás, Zsuzsanna, MacAleenan, Niall, Galli, Maria Cristina, Linē, Aija, Gulbinovic, Jolanta, Berchem, Guy, Fraczek, Mariusz, Menezes-Ferreira, Margarida, Vilceanu, Nela, Hrubisko, Mikulás, Marinko, Petra, Timón, Marcos, Cheng, Wing, Crosbie, George Andrew, Meade, Nick, di Paola, Michelino Lipucci, VandenDriessche, Thierry, Ljungman, Per, D'Apote, Lucia, Oliver-Diaz, Olga, Büttel, Isabel, Celis, Patrick
Format:	Artikel
Sprache:	eng
Schlagworte:	631/154/155 631/154/51/1844 631/154/51/201 631/61/2035 Biomedical and Life Sciences Biomedicine Biotechnology Cancer Cancer Research Care and treatment European Union Genetic Therapy - legislation & jurisprudence Genetic Therapy - methods Government Regulation Humans Medicinal Chemistry Molecular Medicine opinion-2 Pharmacology/Toxicology Stem Cell Transplantation - legislation & jurisprudence Stem Cell Transplantation - methods Tissue Engineering - legislation & jurisprudence
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