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PV WORKSHOP 1: Pharmacovigilance Inspections/audits readiness and procedures to manage these

March 15 - 16, 2021

Pharmacovigilance Inspections/audits readiness and procedures to manage these
PATH & DCVMN consultant
Topics:
1. Specificities of vaccine pharmacovigilance
2. Pharmacovigilance from industry perspective: pre- and post-licensure
3. The PV System Master File (PSMF): Purpose & content

11:00 to 1:00 pm CET

Presenters: Katharina Hartman, External consultant & Varun Sharma (PATH)

Documents
Draft Agenda
_a_who_tool_for_global_use.pdf
best_practices_for_improving_the_quality_of_safety_reports.pdf
guideline_on_good_pharmacovigilance_practices.pdf
implementing_benefit-risk_assessment_for_the_periodic_benefit-risk_evaluation_report.pdf
march_2021_ws__specificities_of_vaccine_pv.pdf
march_2021_ws_vaccine_pv_industry_perspective.pdf
pharmacovigilance_system_master_file_dcvmn_16mar21.pdf
One pager Summary Report