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Session 12: Risk-Based Auditing and the Pharmacovigilance Audit Universe
Session Chair(s)
Yvonne Ditoro, BSN, MBA, RN
Pharmacovigilance Operations Consultant
Yvonne Ditoro and Associates LLC, United States
- FDA and EMA requirements regarding Risk-Based Audits of the Pharmacovigilance System and Quality System
- Recommendations on the design of the pharmacovigilance audit strategy
- Identification of the pharmacovigilance processes and entities subject to pharmacovigilance audits (define the pharmacovigilance audit universe)
- Development of risk assessment methodology
- Implementation of the pharmacovigilance audit strategy plan
- Methods of quality oversight and management of third parties performing pharmacovigilance activities