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 medicine regulators. The statement follows a workshop from 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: harmonization of terminologies; regulatory convergence on guidance and best practice; readiness to address public health challenges and emerging health threats; and 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.
Head of the Real World Evidence (RWE) Workstream
European Medicines Agency
Vice President
Amgen Inc.
Pharmaceuticals and Medical Devices Agency
Associate Director, Office of Medical Policy, CDER
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, PDD, HPFB
Heath Canada/ Santé Canada