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.
Workshop participants discussed the results of three technical ICMRA working groups that focus on vaccines surveillance and vigilance, pregnancy observational research and the building of international cohorts of patients. They acknowledged the importance of these platforms that allow timely sharing of data, experience and tools, which can benefit patients globally.
Medicines regulators from around the world also shared their experience of performing observational studies based on real-world data in the context of COVID-19 and discussed key lessons learnt during the public health emergency. There was broad agreement that rapid generation of evidence as a result of active interactions between regulators, researchers and academia is crucial for regulatory decision-making in case of a new pandemic or other public health crises. Participants also identified opportunities for strengthening international collaboration beyond the pandemic.
The meeting built upon the knowledge and experience gained from a series of ICMRA workshops on COVID-19 observational research held over the past two years. It had participants representing more than 28 medicines regulatory authorities as well as experts from the World Health Organization.
The discussion was moderated by Kelly Robinson, Director General of the Marketed Health Products Directorate at Health Canada and Xavier Kurz, Head of Data Analytics at EMA.
ema.europa.eu
