Tuesday, January 17, 2012

The European Hospital Exemption Clause—New Option for Gene Therapy?

Human Gene Therapy.
Christian J. Buchholz, Ralf Sanzenbacher, and Silke Schüle. January 2012, 23(1): 7-12. doi:10.1089/hum.2011.2529.

Keywords: Gene-therapy medicinal products, authorized clinical trials, centralized procedure, European Medicines Agency, Regulation (EC) No. 1394/2007, cell-therapy products, hospital exemption, exclusive professional responsibility.