Pharmacovigilance Aspects of Licensing Agreements

Whilst licensing agreements involving medicines are primarily driven by commercial factors, the successful handling of pharmacovigilance obligations is a critical, but frequently overlooked, consideration. Negotiating the safety arrangements to ensure regulatory compliance by both partners can be a complex process, which is further compounded by a lack of harmonisation and clarity of the regulations around the world.

This intensive one-day seminar will review the existing global requirements relating to pharmacovigilance in contractual agreements. The emphasis will be on practical advice as to how to remain compliant with the legal obligations and how to satisfy good pharmacovigilance practice and quality management requirements, as well as how to promote harmonious business partnerships.

A practical workshop session will help consolidate the information provided under the guidance of our expert trainers.

Benefits of attending

• Make sense of the licensing agreement jungle
• Ensure you stay compliant with global pharmacovigilance requirements
• Understand what the regulators expect
• Master the essentials of licensing agreements – safety and business considerations
• Consider the legal status and role of pharmacovigilance licensing agreements
• Discuss audit and compliance aspects of third-party agreements