2020 - The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation

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