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Pharmacovigilance Aspects of Licensing Agreements


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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.

Details

Benefits of attending 

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 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.

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.

Prices

TBC

Contact

Leigh White
info@management-forum.co.uk

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