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:
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.
Global regulatory framework
Best pharmacovigilance practices in licensing agreements
Audit and compliance aspects of third-party agreements
Workshop – practical aspects of licensing agreements
Final discussion session and questions
Carol Markwell is a Consultant with more than 30 years experience in pharmacovigilance. She was one of the first to gain the Postgraduate Diploma in Pharmacovigilance from the University of Hertfordshire. In industry she managed a team responsible for international case management, UK/ Eire submissions and the preparation of up to 25 PSURs annually. She then set up own pharmacovigilance consultancy providing assistance and pharmacovigilance solutions to pharmaceutical companies large and small across Europe, from a full PV service to process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, and interim management and offering full PV servi
|2 Apr 2020|
|2 Apr 2020||Cavendish Hotel, London||GBP 699.00
+ VAT @ 20.00%
|9 Oct 2020|
|9 Oct 2020||Venue not yet confirmed||GBP 699.00
+ VAT @ 20.00%
|Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.|