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
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
