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 Principal Consultant at Director Drug Safety Solutions Ltd a consultancy providing assistance and Pharmacovigilance solutions to Pharmaceutical companies large and small across Europe: process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, and interim management. She has worked in Pharmacovigilance since 1988, being 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.
Christine Bendall is a lawyer and PV Consultant. She advises on all aspects of PV systems and compliance and works as a PV auditor. Christine qualified as a solicitor in 1985 and began to concentrate upon regulation in the healthcare sector in 1989. During 1990-1991, she was seconded to the Solicitors Office, UK Department of Health, where she worked as legal advisor to the Department, in particular to the Medicines Control Agency (now MHRA) and its scientific advisory Committees. Following her return to private legal practice, she specialised in European and UK regulatory law relating to the healthcare industry and related sectors, with a special focus on pharmacovigilance. She set up her own consultancy in April 2012.