Die nationale Begleitgesetzgebung zum Genehmigungsverfahren klinischer Prüfungen mit Humanarzneimitteln im Rahmen der Verordnung (EU) Nr. 536/2014

The Regulation (EU) No 536/2014 (Clinical Trials Regulation [CTR]) on clinical trials on medicinal products for human use is a challenge not only for sponsors but also for national authorities and ethics committees. Thus, fundamental structural changes were necessary for the establishment of the nov...

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Detalles Bibliográficos
Autores principales: Frech, Marion, Dexel, Florian, Burgard, Margareta, Seibel, Yvonne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Leitthema
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832104/
https://www.ncbi.nlm.nih.gov/pubmed/36525035
http://dx.doi.org/10.1007/s00103-022-03629-5

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832104/
https://www.ncbi.nlm.nih.gov/pubmed/36525035
http://dx.doi.org/10.1007/s00103-022-03629-5

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