Global Pharmacovigilance and Risk Management Strategies Conference

As safety regulations and guidances are updated, Pharmacovigilance staff must remain aware of key differences to plan effectively, provide high quality reports, and ensure compliance with all timelines. This case study will provide example differences in national and regional requirements encountered in a multinational clinical trial involving safety data collection, serious adverse event (SAE) assessment, expedited and periodic reporting. Diligent regulatory intelligence and good team communication led to more robust study planning and Safety Management Plans. Periodic review of processes and plans continued to be needed as the study progressed

Featured Topics:

• Ensuring diversity of clinical trials while remaining compliant with data protection requirements
• Performing casuality and expectedness assessments of SAEs
• Implementing ICH E2B (R3) regional elements
• Registering and using regulatory reporting portals
• Incorporating national and regional expectations into Development Safety Update Plans (DSURs)