The symposium will focus upon how to set up an outsourcing model that allows client oversight and future flexibility to in-source at a point in the future. Such a system can also be left open such that in times of need there is remaining flexibility once in-sourced to immediately out-source some aspects if the need arises. This will be a case study showing the scope, plan for transition, and what items to leave open for ensuring adaptability once in-sourced.

Learning Objectives:
Identify the scope of Pharmacovigilance activities in a global environment
Describe planning for transition, knowledge, capacity and transparency for staff regulators in Pharmacovigilance activities
Explain the flexibility in systems and activities for future Pharmacovigilance support.