Pharmacovigilance Audits

Ensuring PV Compliance Through Effective Audit Strategies 

• Overview and Conduct of PV Audits: Purpose, scope, preparation, execution, reporting, and follow-up 
• Legal Framework: Key PV regulatory requirements and GVP expectations 
• Audit Strategy and Risk-Based Planning: Risk assessments and prioritization of PV activities, systems, and vendors 
• Common Deficiencies and Case Studies: Typical inspection findings and practical examples

This webinar provides a practical and comprehensive overview of pharma- covigilance audits within the EU regulatory framework and current GVP expectations. Participants will gain insight into the purpose, governance, and strategic value of PV audits, including their role in ensuring compliance, inspection readiness, and continuous quality improvement. The programme covers risk-based audit planning, audit preparation and conduct, reporting, and the management of findings and CAPAs. In addition, participants will explore the integration of audits into the Pharmacovigilance System Master File (PSMF) and the Quality Management System (QMS), including the oversight of vendors and third parties. Practical examples, real-world case studies, and common regulatory inspection findings will help participants translate regulatory expectations into effective audit practices.