As products especially for unmet medical needs become more common, the types and quantities of clinical data available to support a regulatory decision have changed. These changes have been embraced by some agencies but remain a challenge for others. This is especially true when an agency must make an initial decision (or a reliance decision) using Phase 2 or early Phase 3 data only. This session will highlight best practices that can facilitate the use of (and reliance on) early clinical data, including data from novel study designs.
7:11 - Tony Succar (Department of Regulatory and Quality Sciences, USC)
27:45 - Maxime Sasserville (Pharmaceutical Drugs Directorate, Health Canada)
44:30 - Marc Blockman (WHO Collaborating Centre for Medicines Information,
University of Capetown, Representing the South African Health Products Regulatory Authority)