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Session 11: Compliance Management and Monitoring
Session Chair(s)
Yvonne Ditoro, BSN, MBA, RN
Pharmacovigilance Operations Consultant
Yvonne Ditoro and Associates LLC, United States
- Specific quality system procedures and processes that should be in place to ensure compliance with the various required pharmacovigilance activities
- Processes to monitor the performance and effectiveness of a Pharmacovigilance System and its Quality System
- Exercise: Using list of PV activities you prepared in Sessions 3, 4, & 9, identify where you could use KPIs/metrics.