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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Bibliografische gegevens
Gepubliceerd in:Br J Clin Pharmacol
Hoofdauteurs: 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
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: John Wiley and Sons Inc. 2016
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Clinical Trials
Online toegang: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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