A pharmacovigilance agreement (PVA) is a written agreement between a marketing authorization holder (MAH) and a third party to which the MAH has shared activities regarding or impacting pharmacovigilance. It outlines the responsibilities of each party. Therefore, PVAs preparation and management are an integral part of a solid pharmacovigilance system.
The goal of the training is to get an overview of the array of provisions that are included in PVAs and discuss current hot topics regarding PVAs. The course will also consider whether a full PVA is always necessary, i.e., when inclusion of PV language into the underlying commercial agreement may be sufficient and what this language could look like. We will explore current hot topics in this regard, so the audience understands both current best practice and how this best practice may evolve in the next few years.