In a dedicated COVID-19 workshop, organised by the European Medicines Agency (EMA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed how data generated during clinical practice could complement evidence from clinical trials with potential therapeutics or vaccines against COVID-19. Participants from more than 25 countries, representing 28 medicines regulatory authorities globally and experts from the World Health Organization and the European Commission acknowledged the importance of observational studies of real world data for increasing the effectiveness and efficiency of regulatory processes and decision-making in the development, authorisation and monitoring of medicines and vaccines to prevent and treat COVID-19 and to address knowledge gaps that cannot be addressed by clinical trials.
source https://www.pharmatutor.org/pharma-news/2020/global-regulators-discuss-observational-studies-of-real-world-data-for-covid-19-medicines
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