Course overview
Licensing agreements for medicines may be commercially driven, but overlooking pharmacovigilance obligations can create significant regulatory risk. Ensuring both partners meet their safety responsibilities requires careful negotiation, particularly in a global landscape where regulations often lack harmonisation and clarity. Getting these arrangements right is not just a legal necessity, it is essential for protecting patients and sustaining successful collaborations.
This intensive one-day course offers a focused exploration of global pharmacovigilance requirements within contractual agreements. It brings the subject to life with practical insights on maintaining compliance with legal obligations, meeting good pharmacovigilance practice and quality management standards, and building strong, cooperative partnerships between organisations.
To reinforce learning, the workshop session allows delegates to apply key concepts in a guided, practical setting, supported by expert trainer, Graeme Ladds, who bring real-world experience to the discussion. By the end of the course, delegates will be better equipped to navigate the complexities of pharmacovigilance in licensing agreements with confidence and clarity.
CPD Hours: 6
Course Content
- Day 1
- Global regulatory framework
- Best pharmacovigilance practices in licensing agreements
- Legal aspects
- Audit and compliance aspects of third-party agreements
- Workshop - practical aspects of licensing agreement
Speakers
Joanne Flitcroft
Joanne Flitcroft is a qualified solicitor with over 22 years’ experience. She trained in the City of London and later specialised in pharmacovigilance as part of a FTSE 100 pharmaceutical company’s global legal team. Joanne founded Opallios in 2016, a legal consultancy providing advice to companies operating in the life sciences sector. Her clients include pharmaceutical companies, CROs and health communications companies. Joanne is a Non-Executive Director on the Board of the British Society of Gastroenterology, a Governor on the Board of Edge Hill University and a school governor. She has travelled across West Africa in a Ford Fiesta and besides travel, enjoys spending her spare time pursuing her interest in the classics.
Graeme Ladds
Graeme Ladds, Director of PharSafer, has over 30 years’ experience in the pharmaceutical industry. He began his career in 1989 at Ashbourne Pharmaceuticals as Head of Drug Safety & Medical Information, before going on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
He later founded his consultancy and specialist CRO, PharSafer Associates Ltd, where he has supported companies in establishing pharmacovigilance systems, conducting audits across Europe and the USA, developing SOPs, acting as a QP, and supporting regulatory inspections.
Since 1994, Graeme has also been involved in the monitoring of medical devices, including drug-device combinations, structural devices and electrical medical devices. His experience spans clinical trials and global device vigilance, alongside pharmacovigilance activities across both clinical development and post-marketing phases.
