by Syneos Health_1 | 21 Aug, 2019 | EMA, Real Word Evidence, Real World Research Design, Regulatory Grade RWE
Source: Cave, A. , Kurz, X. and Arlett, P. (2019), Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe. Clin. Pharmacol. Ther., 106: 36-39. doi:10.1002/cpt.1426 Real-world data (RWD) offers the possibility to derive novel...
by Syneos Health_1 | 25 Jun, 2019 | EMA, Regulatory Science
“The regulatory science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said Guido Rasi, EMA’s Executive Director. “The strategy includes developments and challenges in medicines...