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PV WORKSHOP 2: Pharmacovigilance Inspections/audits readiness and procedures to manage these

April 15, 2021

Workshop: Pharmacovigilance Inspections/audits readiness and procedures to manage these
PATH & DCVMN consultant
1. Role of QPPV, staff and management
2. Training of personnel for pharmacovigilance
3. Facilities and equipment for pharmacovigilance
4. Contractual agreements

Registration link:
https://dcvmn.webex.com/dcvmn/onstage/g.php?MTID=ee5b5352e295aad1ff4d025797eb5ffdf
Event password: PVaudits2

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

Click here to access the recording of the event

Documents
Draft Agenda
1. QPPV Katharina Hartmann
2. Facilities equipment training and agreements for PV Varun Sharma
One pager Summary Report