E-workshop on Vaccine Safety monitoring and Pharmacovigilance tools

Documents

• Presentation - Case Management (PDF - 1.2 Mb)
• One-pager summary report - E-workshop on Pharmacovigilance 2020 (PDF - 92.5 kb)
• Presentation - PQC Handling (PDF - 628.8 kb)
• Presentation - PSUR Best Practices (PDF - 1.1 Mb)
• Presentation - PV Audit Checklist (PDF - 157.3 kb)
• Presentation - PV QMS (PDF - 131.2 kb)
• Presentation - Signal and Risk Management (PDF - 805.3 kb)

Agenda

• Agenda - E-workshop on Pharmacovigilance 2020 (PDF - 449.8 kb)

Speakers Book

• Speakers booklet - E-workshop on Pharmacovigilance 2020 (PDF - 374.5 kb)

Pre-reading material

• Pre-reading: Best practices for improving the quality of individual case safety reports (ICSRs) in Pharmacovigilance (PDF - 572.9 kb)
• Pre-reading: Assessment of causality of individual adverse events following immunization(AFI) (PDF - 979.8 kb)
• Pre-reading: Implementing Benefit-Risk Assessment for Periodic Benefit-Risk Evaluation Report (PBRER/PSUR) (PDF - 536.2 kb)