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How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
Tafuri G, Pagnini M, Moseley J, Massari M, Petavy F, Behring A, Catalan A, Gajraj E, Hedberg N, Obach M, Osipenko L, Russo P, Van De Casteele M, Zebedin EM, Rasi G, Vamvakas S. Tafuri G, et al. Among authors: obach m. Br J Clin Pharmacol. 2016 Oct;82(4):965-73. doi: 10.1111/bcp.13023. Epub 2016 Jul 1. Br J Clin Pharmacol. 2016. PMID: 27245362 Free PMC article.
The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.
Tafuri G, Lucas I, Estevão S, Moseley J, d'Andon A, Bruehl H, Gajraj E, Garcia S, Hedberg N, Massari M, Molina A, Obach M, Osipenko L, Petavy F, Petschulies M, Pontes C, Russo P, Schiel A, Van de Casteele M, Zebedin-Brandl EM, Rasi G, Vamvakas S. Tafuri G, et al. Among authors: obach m. Br J Clin Pharmacol. 2018 May;84(5):1013-1019. doi: 10.1111/bcp.13524. Epub 2018 Mar 5. Br J Clin Pharmacol. 2018. PMID: 29370449 Free PMC article.
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Moseley J, Vamvakas S, Berntgen M, Cave A, Kurz X, Arlett P, Acha V, Bennett S, Cohet C, Corriol-Rohou S, Du Four E, Lamoril C, Langeneckert A, Koban M, Pasté M, Sandler S, Van Baelen K, Cangini A, García S, Obach M, Gimenez Garcia E, Varela Lema L, Jauhonen HM, Rannanheimo P, Morrison D, Van De Casteele M, Strömgren A, Viberg A, Makady A, Guilhaume C. Moseley J, et al. Among authors: obach m. Br J Clin Pharmacol. 2020 Jun;86(6):1034-1051. doi: 10.1111/bcp.14279. Epub 2020 Apr 24. Br J Clin Pharmacol. 2020. PMID: 32162368 Free PMC article. Review.
42 results