PV audits & inspection strategies - Day 1: Risk based PV audits

A risk based audit approach helps to identify the areas of highest risk to the organisation's Pharmacovigilance system, including its quality system for Pharmacovigilance activities. Moreover, it acknowledges the internal audit to provide assurance to the authorities that the risk management processes are managing risks effectively. After attending the seminar you will be able to - prepare a strategic long term plan; - identify the PV activities and processes subject to PV audit; and - develop risk assessment criteria.