Pharmacovigilance Aspects of Licensing Agreements
- The Cavendish Hotel London
- Jermyn Street
- Greater London
- SW1Y 6JF
- United Kingdom
- View on a map
- More Information:
- Organiser: Management Forum
- Name: Leigh White
- Email: email@example.com
Whilst licensing agreements involving medicines are primarily driven by commercial considerations, 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. This is further compounded by a lack of harmonisation and clarity of the regulations around the world.
This 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 how to satisfy good pharmacovigilance practice and quality management requirements, as well as how to promote harmonious business partnerships.
Key issues to be addressed:
- Making sense of the licensing agreement jungle
- How to stay compliant with global pharmacovigilance requirements n Understand what the regulators expect
- Essentials of licensing agreements – safety and business considerations
- Understand the legal status and role of pharmacovigilance licensing agreements
- Discuss audit and compliance aspects of third-party agreements
Who should attend
This programme will be of interest to all personnel involved in business development and licensing agreements, including those working in drug safety and pharmacovigilance, regulatory affairs and drug registration, medical directors, R&D directors and company lawyers.