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Virtual Training Course (US Eastern Time)

Aug 10, 2020 9:00 AM - Aug 13, 2020 1:15 PM

The Pharmacovigilance Quality Management System

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Session 12: Risk-Based Auditing and the Pharmacovigilance Audit Universe

Session Chair(s)

Yvonne Ditoro, BSN, MBA, RN

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
Risk Assessment Workshop

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