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Dynamic Regulatory Assessment: Unpacking the Process Reveals Readiness to Pilot for Europe-An EFPIA View.

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第一作者： Iain,Todd

第一单位： GSK, Brentford, United Kingdom. Electronic address: iain.t.todd@gsk.com.

作者： Iain,Todd ^[1] ; Ruediger,Faust ^[2] ; Esteban,Herrero-Martinez ^[3] ; Nasir,Hussain ^[4] ; Adam,Kawinski ^[5] ; Andrew,Lennard ^[6] ; Nadege Le,Roux ^[7] ; Judith,Macdonald ^[8] ; Mark,Mayer ^[9] ; Rodrigo,Palacios ^[10] ; Agnès,Dangy-Caye ^[11]

作者单位： GSK, Brentford, United Kingdom. Electronic address: iain.t.todd@gsk.com. ^[1] UCB Biosciences GmbH, Monheim am Rhein, Germany. ^[2] AbbVie Ltd, Maidenhead, United Kingdom. ^[3] Gilead Sciences, Uxbridge, United Kingdom. ^[4] Boehringer Ingelheim International GmbH, Biberach, Germany. ^[5] Amgen Ltd, Uxbridge, United Kingdom. ^[6] Celgene, a Bristol Myers Squibb company, Boudry, Switzerland. ^[7] Pfizer Research and Development Ltd, Tadworth, United Kingdom. ^[8] Eli Lilly and Company, Indianapolis, Indiana, USA. ^[9] F. Hoffmann-La Roche, Basel, Switzerland. ^[10] Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France. Electronic address: agnes.dangy-caye@sanofi.com. ^[11]

关键词 Discrete data packets Dynamic regulatory assessment Evidence release and assessment Iterative regulatory dialogue

医学主题词人类(Humans);欧洲(Europe);制药工业(Drug Industry);药品和麻醉品检定(Drug and Narcotic Control)

DOI 10.1016/j.clinthera.2023.08.006

PMID 37704457

发布时间 2024-04-16

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