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Session 14: Pharmacovigilance Inspections and Inspection Readiness
Session Chair(s)
Yvonne Ditoro, BSN, MBA, RN
Pharmacovigilance Operations Consultant
Yvonne Ditoro and Associates LLC, United States
- The types and scopes of pharmacovigilance inspections
- The role of the PSMF in ensuring Marketing Authorization Holders and pharmacovigilance units remain inspection ready
- How to prepare for inspections and be inspection ready
- Checklists for planned and unplanned inspections, and tips on being the interviewee
- Exercise: Each participant will write on a Zoom whiteboard, one test question related to Session 14