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Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World.
Clin Ther. 2022 Mar;44(3):420-437. doi: 10.1016/j.clinthera.2022.01.012. Epub 2022 Feb 15.
Clin Ther. 2022.
PMID: 35181179
Free article.
Review.
Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health-an EFPIA View.
Herrero-Martinez E, Hussain N, Roux NL, MacDonald J, Mayer M, Palacios R, Kühler TC.
Herrero-Martinez E, et al. Among authors: roux nl.
Clin Ther. 2022 Jan;44(1):132-138. doi: 10.1016/j.clinthera.2021.11.001. Epub 2021 Nov 27.
Clin Ther. 2022.
PMID: 34848082
Free PMC article.
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Dynamic Regulatory Assessment: Unpacking the Process Reveals Readiness to Pilot for Europe-An EFPIA View.
Todd I, Faust R, Herrero-Martinez E, Hussain N, Kawinski A, Lennard A, Roux NL, Macdonald J, Mayer M, Palacios R, Dangy-Caye A.
Todd I, et al. Among authors: roux nl.
Clin Ther. 2023 Nov;45(11):1142-1147. doi: 10.1016/j.clinthera.2023.08.006. Epub 2023 Sep 11.
Clin Ther. 2023.
PMID: 37704457
Free article.
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A Future European Scientific Dialogue Regulatory Framework: Connecting the Dots.
Hey C, Hunter A, Muller M, Roux NL, Bennett S, Nowok K, Oliveira L.
Hey C, et al. Among authors: roux nl.
Clin Ther. 2024 Mar;46(3):293-299. doi: 10.1016/j.clinthera.2023.12.006. Epub 2024 Jan 15.
Clin Ther. 2024.
PMID: 38228459
Free article.
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