EU Mandates Monthly Safety Summaries For Approved COVID-19 Vaccines
EU regulators have agreed on supplementary pharmacovigilance requirements applicable to COVID-19 vaccines following approval.
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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.
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.
In the second segment of a two-part article on transparency provisions for the new EU clinical trial portal, a senior Merck executive explains how the company will ensure that commercially sensitive information and personal data in its clinical trial applications are not made public.