Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018

The EU is a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and therefore adopts the ICH Guidelines, including the ICH M3 Guideline on Nonclinical Safety Studies. Following the 2016 incident in France with BIA 10-2474, and in l...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Therapeutic innovation & regulatory science 2020-03, Vol.54 (2), p.462-467
Hauptverfasser:	van der Laan, Jan Willem, Benson, Charles T., Janssens, Walter, Bos, Jeroen, Stahl, Elke, Brady, Joseph T., Wändel-Liminga, Ulla, Corriol-Rohou, Solange, Forster, Roy, Hartmann, Andreas, Pertel, Peter Einar, Robertson, Sarah M., Silva-Lima, Beatriz, Malik, Raleigh E., Chibout, Salah-Dine
Format:	Artikel
Sprache:	eng
Schlagworte:	Case studies Clinical trials Drug Safety and Pharmacovigilance Medicine Pharmacotherapy Pharmacy Regulators Research programs Risk assessment Safety Session Proceedings
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!