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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Detalles Bibliográficos
Autores principales: 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: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Clinical Trials
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137821/
https://www.ncbi.nlm.nih.gov/pubmed/27245362
http://dx.doi.org/10.1111/bcp.13023

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137821/
https://www.ncbi.nlm.nih.gov/pubmed/27245362
http://dx.doi.org/10.1111/bcp.13023

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