Bewertung klinischer Arzneimittelprüfungen durch Ethikkommissionen: Änderungen durch die neue EU-Verordnung 536/2014 (CTR) und nötige Harmonisierungsmaßnahmen

After Regulation (EU) No. 536/2014 (Clinical Trial Regulation, CTR) of the European Parliament and of the Council took effect on 31 January 2022, the application process for clinical trials fundamentally changed. This article describes the fundamental procedural changes and the resulting changes for...

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Detalles Bibliográficos
Autores principales: Raffauf-Seufert, Claudia, Grass, Guido
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Leitthema
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832068/
https://www.ncbi.nlm.nih.gov/pubmed/36472643
http://dx.doi.org/10.1007/s00103-022-03627-7

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9832068/
https://www.ncbi.nlm.nih.gov/pubmed/36472643
http://dx.doi.org/10.1007/s00103-022-03627-7

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