On 19 May 2020 at a second workshop on observational studies co-organised by the EMA and Health Canada within the International Coalition of Medicines Regulatory Authorities, international regulators agreed to step up their cooperation in the following three areas:
• Pregnancy research
to examine the impact of both coronavirus disease and medication use on pregnant women infected with SARS-CoV-2 and on their unborn babies in order to support COVID-19 medicine development, risk management, and planning for safety monitoring of vaccines and therapeutics;
• Building international clinical cohorts of COVID-19 patients
to share expertise and increase study power and data quality in order to meet regulatory requirements and address existing knowledge gaps; and
• Prepare strong infrastructure for monitoring the safety and effectiveness of vaccines against COVID-19 in order to rapidly detect and minimise risks to patients.
Meeting participants agreed that global collaboration on observational studies of real-world data will help not only to contribute to the COVID-19 response but also to leave enduring legacy for future international observational research beyond the ongoing pandemic.