The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation

Learning Objectives:

Upon completing of this course, participants should be able to:

• Understand the legal requirements and health authority expectations for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
  • Develop a high-level PV audit strategy
  • Identify the PV activities and processes subject to PV audit
  • Develop risk assessment criteria
  • Identify the PV audit universe – entities subject to PV audit
  • Categorize the entities subject to PV audit
  • Perform risk assessments
  • Prioritize entities for audit according to relative risk
  • Prepare a 3-5 year PV audit plan
• Identify procedures/tools to monitor PV quality of third parties