by Syneos Health_1 | 19 Nov, 2018 | 21 Century Cures Act, CHCUK News & Articles, Consultation, Real Word Evidence, Registry, Regulatory Grade RWE
Use of patient disease registries for regulatory purposes (new) On 8 November 2018 the EMA cross-committee task force published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes:...
by Syneos Health_1 | 19 Nov, 2018 | CHCUK News & Articles, Digital Health Technology, Real Word Evidence
Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation Source: Pacurariu A, Plueschke K, McGettigan P, et al. Electronic healthcare databases in Europe: descriptive analysis of characteristics...
