Pharmacovigilance Audit and Inspections activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.
To this end, pharmaceutical organizations must be able to provide evidence of strong standard operating procedures—on demand. Yet, even today, a majority of companies are still struggling to fulfill their obligations, potentially causing marketing authorization holders (MAHs) to fail inspections, incur fines, and see products withdrawn from markets.
This webinar will give you an insight into the readiness and management as well as practical tips of what works well and where the challenge may be as well as sharing real experiences.
- Regulatory Framework Applicable to PV Inspections and Audits
- PV Audits and Inspections Principles and Operational Differences
- Pharmacovigilance Audit and Inspection Readiness from Auditee and Inspected Perspective
- PV Audit and Inspection Follow-Up
