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Session 5: Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Quality Manual
Session Chair(s)
Yvonne Ditoro, BSN, MBA, RN
Pharmacovigilance Operations Consultant
Yvonne Ditoro and Associates LLC, United States
- Overview and description of the Pharmacovigilance System Master File (PSMF) and the Pharmacovigilance Quality Manual
- Review requirements, content, and maintenance for these documents
- Quality Manual Template Workshop
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