How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

BACKGROUND: In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development pla...

תיאור מלא

שמור ב:
מידע ביבליוגרפי
הוצא לאור ב:Br J Clin Pharmacol
Main Authors: Tafuri, Giovanni, Pagnini, Margherita, Moseley, Jane, Massari, Marco, Petavy, Frank, Behring, Antje, Catalan, Arantxa, Gajraj, Elangovan, Hedberg, Niklas, Obach, Mercè, Osipenko, Leeza, Russo, Pierluigi, Van De Casteele, Marc, Zebedin, Eva‐Maria, Rasi, Guido, Vamvakas, Spiros
פורמט: Artigo
שפה:Inglês
יצא לאור: John Wiley and Sons Inc. 2016
נושאים:
Clinical Trials
גישה מקוונת:https://ncbi.nlm.nih.gov/pmc/articles/PMC5137821/
https://ncbi.nlm.nih.gov/pubmed/27245362
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13023
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