Pharmacovigilance Aspects of Licensing Agreements Training Course

This course provides a focused and practical understanding of pharmacovigilance obligations within licensing and commercial agreements an area that is often underestimated but critical for maintaining global regulatory compliance.

As partnerships between companies become increasingly complex, so too do the responsibilities for managing safety data and ensuring alignment with international regulations. This training explores how pharmacovigilance requirements fit within contractual frameworks, highlighting the challenges posed by differing global expectations and the need for clear, well-defined responsibilities between partners.

Participants will gain a solid understanding of the global regulatory landscape and how it impacts licensing arrangements, alongside the expectations placed on Marketing Authorisation Holders (MAHs) and their partners. The course also addresses how to design, implement, and manage pharmacovigilance agreements that meet both legal and regulatory standards, while supporting effective and collaborative business relationships.

With a strong emphasis on real-world application, the course provides practical guidance on drafting agreements, defining responsibilities, and ensuring compliance through audits and ongoing oversight. Interactive elements, including workshop sessions, allow participants to apply their knowledge in realistic scenarios, strengthening their ability to manage pharmacovigilance requirements confidently within licensing agreements.

By the end of the course, attendees will be equipped with the knowledge and practical skills needed to navigate pharmacovigilance responsibilities in partnerships, reduce compliance risk, and support successful, inspection-ready agreements.