PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation covers topics such as:
- 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
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation brings together:
- PV Compliance professionals
- PV Quality Assurance Staff
- Pharmacovigilance Auditors
- Quality auditors
- PV Service Provider Relationship Managers
- Relevant Pharmacovigilance Staff
- MAH Affiliates responsible for Pharmacovigilance