New EMA System By Year End To Monitor COVID-19 Vaccine Safety
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.
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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.
The European Medicines Agency is taking steps to establish infrastructure for monitoring COVID-19 vaccines whenever they reach the European market.
There is much talk around the importance of clinical trials in finding new treatments and vaccines for COVID-19 patients, but observational studies in clinical practice also have a vital role to play, including the impact on pregnant women.