This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
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.
* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Global regulatory framework
- EU, USA and what ICH says
- How it impacts partnerships
- What the regulators expect
- from the pharmacovigilance system
- from the MAH
- from the MAH’s partners
Best pharmacovigilance practices in licensing agreements
- Types of agreement
- Safety Data Exchange
- Who is responsible for what
- Joint handling of pharmacovigilance issues
- The legal status and role of pharmacovigilance agreements
- Drafting pharmacovigilance agreements
- contract basics, dos and don’ts
- terminology, form and content
- using templates
- Contractual liability and indemnities
- Amendment and termination of pharmacovigilance agreements
Audit and compliance aspects of third-party agreements
- Regulatory expectations and inspections
- Which agreements to examine at audit
- What to look for in safety data exchange agreements at pharmacovigilance audit
- Which partners to audit and how
- Measuring partner/other party compliance
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.
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.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.