Virtual Training Course (US Eastern Time)

2020年8月10日 (月) 午前 9:00 - 2020年8月13日 (木) 午後 1:15

The Pharmacovigilance Quality Management System

Session 14: Pharmacovigilance Inspections and Inspection Readiness

Session Chair(s)

Yvonne  Ditoro, BSN, MBA, RN

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

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