Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global regulatory workshop on COVID-19 observational studies and real-world data. The workshop, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), was co-chaired by Health Canada and the European Medicines Agency (EMA) and took place on 20 May 2022. The main findings of the workshop are summarised in a report.
International regulators are working together to enhance global capabilities for observational research in the context of the COVID-19 pandemic and beyond. Real-world evidence generated from observational research is critical to understanding the safety and effectiveness of medicines when used in clinical practice for the prevention and treatment of COVID-19…
