Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.
Learning Objectives
Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
