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Session 8: Pharmacovigilance in the Study and Clinical Trial Environment
Session Chair(s)
Yvonne Ditoro, BSN, MBA, RN
Pharmacovigilance Operations Consultant
Yvonne Ditoro and Associates LLC, United States
- Review of study classification, causality assessments, expedited reporting, reference safety information, and other areas subject to pharmacovigilance audits and inspections
- Pharmacovigilance-related clinical processes and cross-functional SOPs
- Safety Management Plans, when they are required, and key elements to include
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