Real-World Evidence in Regulatory Decision-Making: Enabling its Use Through International CReal-World Evidence in Regulatory Decision-Making: Enabling its Use Through International Collaboration
1:00 PM - 2:00 PM (EDT), Monday, June 5, 2023 ・ Session Room 204AB
To further exploit the full potential of real-world data (RWD) to generate evidence suitable to inform regulatory decision-making, the International Coalition of Medicines Regulatory Authorities (ICMRA) has recently issued a statement calling for international collaboration of medicines regulators. The statement follows a workshop in June 2022, co-organised by EMA, US FDA and Health Canada to discuss the challenges of generating reliable real-world evidence (RWE) from different sources and subject to different governance models. The workshop identified 4 main areas for closer cooperation: (i) harmonisation of terminologies; (ii) regulatory convergence on guidance and best practice; (iii) readiness to address public health challenges and emerging health threats; and (iv) transparency. The session will discuss the opportunities for collaboration in these areas to help overcome common challenges and further enable integration of RWE into regulatory decision-making.
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, PDD, HPFB
Heath Canada/ Santé Canada