The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholders' concerns
Cytotherapy
.
2014 Dec;16(12):1597-600.
doi: 10.1016/j.jcyt.2014.08.007.
Epub 2014 Oct 5.
Authors
Natividad Cuende
1
,
Christelle Boniface
2
,
Christopher Bravery
3
,
Miguel Forte
2
,
Rosaria Giordano
4
,
Martin Hildebrandt
5
,
Ander Izeta
6
,
Massimo Dominici
7
;
Legal and Regulatory Affairs Committee—Europe, International Society for Cellular Therapy
Affiliations
1
Andalusian Initiative for Advanced Therapies, Servicio Andaluz de Salud, Junta de Andalucía, Sevilla, Spain. Electronic address: natividad.cuende.sspa@juntadeandalucia.es.
2
TxCell SA, Valbonne, Sophia Antipolis, France.
3
Consulting on Advanced Biologicals Ltd. London, United Kingdom.
4
Cell Factory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
5
TUMCells Interdisciplinary Center for Cellular Therapies, Technische Universität München, instead of. Munich, Germany.
6
Tissue Engineering Laboratory, Instituto Biodonostia, Hospital Universitario Donostia, San Sebastian, Spain.
7
Laboratory of Cell Biology and Advanced Cancer Therapies, University Hospital of Modena and Reggio Emilia, Modena, Italy.
PMID:
25293816
DOI:
10.1016/j.jcyt.2014.08.007
No abstract available
MeSH terms
Europe
Hospitals*
Humans
Marketing of Health Services*
Pharmacovigilance*