This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
2 Oct 2018
& 2 Apr 2019
GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 10 Aug
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.
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 session – Practical aspects of licensing agreements
Sophie Candlin (2 Oct 2018)
As a Patient Safety Specialist at AstraZeneca, Sophie was involved in case processing, literature searching, clinical study support and regional adverse event awareness training . She also provided 3 months on-site training and mentoring to the new data entry team in Budapest when the function was outsourced in 2009.
Sophie moved to Hospira in 2010 where her responsibilities included periodic reporting, risk management plans, quality and compliance, and product labelling. During this time, she travelled to the Philippines to set up and train a new data entry team. Sophie became team leader, directly managing the EMEA Product Safety team.
In 2014, Sophie joined the consultancy Drug Safety Solutions Ltd, where she now works with clients to meet all of their Pharmacovigilance needs, including writing and managing PSMF’s and SOP’s, risk management plan and acting as QPPV.