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

Development of risk assessment methodology for various aspects of PV world (for instance computerized systems, market research, patient support programmes, vendors, processes etc)
Development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan.
The design of the PV audit strategy and tactical PV audit plan/schedule.
Identification of the PV processes and entities subject to PV audit (understanding how to define the PV audit universe)