Pharmacovigilance Agreements

• Practice-oriented introduction to pharmacovigilance contracts: when they are required and why they are crucial for compliance
• Overview of contract types and their use in different cooperation models within the pharmaceutical industry
• Key contractual elements including role allocation, reporting timelines, audit provisions, and safety data management
• Case studies to directly apply the acquired knowledge in practice

The aim of this seminar is to provide participants with a practical intro- duction to the contractual fundamen- tals and requirements of pharma- covigilance. Contracts governing medicinal product safety—so-called Pharmacovigilance Agreements (PVAs)—are a central component of regulatory compliance in the pharma- ceutical industry. During the seminar, participants will learn in which situations such contracts are required, which types of contracts exist, and how they are applied depending on the respective cooperation model (e.g. licensing agreements, contract manufacturing, co-marketing). In addition, the seminar provides a solid understanding of the typical contents of a PVA, including the allocation of roles and responsibilities, reporting timelines, provisions on signal mana- gement, audits, and other minimum contractual requirements in accordance with GVP. Through interactive exercises using realistic case studies and contract excerpts, the acquired knowledge is directly transferred into practice. Participants will thus be enabled to confidently classify, understand, and critically assess PVAs—both from an operational and a strategic perspective.