Real-world data/evidence

CIRS RD Briefing 85 – New drug approvals in six major authorities 2012-2021

This Briefing presents the results from the CIRS annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]

Jenny Sharpe2022-06-28T08:17:34+00:00June 28th, 2022|Tags: Facilitated regulatory pathways, Real-world data/evidence, Regulatory, Work sharing|

2016 Workshop report – RWD to RWE for assessing efficacy and effectiveness

Real-world data to real-world evidence for assessing efficacy and effectiveness: Opportunities and challenges for new medicines development, regulatory review and health technology assessment 23-24 JUNE 2016 TYSONS CORNER, VIRGINIA, [...]

Jenny Sharpe2021-12-24T13:33:18+00:00June 24th, 2016|Tags: Real-world data/evidence|