EMA creates framework to monitor coronavirus (COVID-19) treatments and vaccines

EMA creates framework to monitor coronavirus (COVID-19) treatments and vaccines

The European Medicines Agency (EMA) has developed an infrastructure to support the monitoring of the efficacy and safety of coronavirus (COVID-19) treatments and vaccines when used in day-to-day clinical practice. The EMA has signed three contracts for observational research with academic and private partners, namely, Utrecht University and the University Medical Center Utrecht, IQVIA and the ACCESS project, to effectively monitor vaccines in the real world as soon as they are authorised, and support the safe and effective use of coronavirus vaccines and medicines. Data on the impact of coronavirus in pregnancy will be collected, a framework for the conduct of multicentre cohort studies on the use of medicines in coronavirus patients will be developed, and preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of coronavirus vaccines in clinical practice will be carried out.

Source: COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines

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