EMA All Set To Oversee Use Of COVID-19 Treatments, Vaccines In Clinical Practice
Three Observational Research Projects Were Signed In Three Months
The European Medicines Agency has finalized infrastructure to monitor the safety and effectiveness of COVID-19 medicines and vaccines when they are used in day-to-day clinical practice following marketing authorization.
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An EU guideline on the methodological aspects of pharmacoepidemiology has been updated to promote collaboration by researchers on high-quality, multi-centre observational studies in the context of COVID-19.
The European Medicines Agency is taking steps to establish infrastructure for monitoring COVID-19 vaccines whenever they reach the European market.
During a virtual workshop with global drug regulators, the European Medicines Agency discussed its plans to build a new EU system to track the safety of COVID-19 vaccines. Also, regulators agreed on exchanging information on observational studies and real-world data relating to the coronavirus pandemic.