Whilst licensing agreements involving medicines are primarily driven by commercial factors, 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, which is further compounded by a lack of harmonisation and clarity of the regulations around the world.
This intensive one-day 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 and how to satisfy good pharmacovigilance practice and quality management requirements, as well as how to promote harmonious business partnerships.
A practical workshop session will help consolidate the information provided under the guidance of our expert trainers.
Benefits of attending
- Make sense of the licensing agreement jungle
- Ensure you stay compliant with global pharmacovigilance requirements
- Understand what the regulators expect
- Master the essentials of licensing agreements - safety and business considerations
- Consider the legal status and role of pharmacovigilance licensing agreements
- Discuss audit and compliance aspects of third-party agreements
Certification:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
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 Agreement
- Who is responsible for what?
- Joint handling of pharmacovigilance issues
Legal aspects
- 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 - practical aspects of licensing agreement
Speakers
Mr Graeme Ladds,
Director ,
PharSafer Associates Ltd.Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
Joanne Flitcroft,
OpalliosJoanne 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.
Who Should Attend
The 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.
