PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

Topics

• Design of the PV audit strategy
• EMA and FDA requirements regarding Risk Based audits
• Strategic level audit planning
• Identification of the PV processes and entities subject to PV audit
• Safety data exchange agreements (SDEAs) and vendor contracts
• Risk assessment criteria
• Risk assessments
• Categorization of the entities (PV Audit Universe)
• 3-5 year PV audit plan
• Prioritization of entities for audit according to relative risk
• Identify procedures/tools to monitor PV quality for oversight of third parties
• Procedural documents, e.g. SOPs

Who should Attend

• PV Compliance professionals
• PV Quality Assurance Staff
• Pharmacovigilance Auditors
• Quality auditors
• PV Service Provider Relationship Managers
• Relevant Pharmacovigilance Staff
• MAH Affiliates responsible for Pharmacovigilance