The Pharmacovigilance Audit

Course Content:

 This module will give you a jump-start on how to prevent common problems that are found during regulatory inspections for drug safety and pharmacovigilance. It includes examples based on the top ten findings by US and EU pharmacovigilance inspectors. You will be able to use this information straight away to make the changes you need to address these common failings and avoid the findings. You can be sure regulatory authorities will inspect your drug safety operations – and there is no excuse for poor preparation.

• Audits vs Inspections
• Types of Audits & Inspections
• Approaches
• Preparing for a Pharmacovigilance Inspection
• Overview of the Pharmacovigilance Audit
• Best Practices
• Detailed Audit Items:
  • Collection
  • Assessment
  • Reporting
  • Analysis
  • Additional Audit Items
• PV Checklist
• Pharmacovigilance Risk Profile
• Top Ten Inspection Findings
• How to Address Inspection Findings?
• Conclusion
• Quiz on Module 3