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...

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Detalhes bibliográficos
Publicado no: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
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2016
Assuntos:
Clinical Trials
Acesso em linha: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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