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PV WORKSHOP 3: Pharmacovigilance Inspections/audits readiness and procedures to manage these, AND Maintain product safety committee/board operational

May 12 - 13, 2021

Workshop 3: Pharmacovigilance Inspections/audits readiness and procedures to manage these, AND Maintain product safety committee/board operational
PATH & DCVMN consultant
1. Documentation and record management
2. Compliance monitoring and system performance
3. Critical pharmacovigilance processes and business continuity

Pre-reading material
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-their-quality-systems_en.pdf

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-rev-2_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-iii-pharmacovigilance-inspections_en.pdf
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-iv-pharmacovigilance-audits-rev-1_en.pdf

RECORDINGS
Access the recording of Day 1 here
Access the recording of Day 2 here

Documents
Draft Agenda
Day 1 Varun Sharma
Day 2 Katharina Kartmann
One pager report