In the past, the primary role of a pharmaceutical company¡¯s affiliate office was to liaise with local health authorities. However, with the harmonisation and globalisation of pharmacovigilance regulations, its role has been extended and responsibilities are more stringent.
These factors have resulted in dramatic changes in the role of the local affiliate office, and there is a risk that local pharmacovigilance activities are being overlooked.
Join us to learn about some of the challenges that marketing authorisation holders (MAH) can face with local pharmacovigilance activities. We will explore how an outsourced affiliate model can provide access to skilled resources with local expertise providing scalability, transparency and the standardisation required to improve regulatory compliance and enable MAH and Qualified Person for Pharmacovigilance (QPPV) oversight. Topics and learnings include:
- The requirements for local and qualified persons for pharmacovigilance
- Potential challenges with local pharmacovigilance activities
- How to get the best outcome from an outsourced affiliate model
Audience:
- Pharmacovigilance
- Regulatory
- Medical
- Clinical Operations
Presenters:
Andrew Purchase
Andrew Purchase has over 17 years of industry experience, holding positions within big pharma and clinical research organisations. As Director of Pharmacovigilance Specialised Services at ÃÛÌÒ´«Ã½, Andrew leads a team of Safety Scientists, many of whom serve as Local Persons for Pharmacovigilance.
Andrew oversees the build out of ÃÛÌÒ´«Ã½s Local Person for Pharmacovigilance (LPPV) network and is actively serving as a UK Qualified Person for Pharmacovigilance (UK QPPV).
Frida Olsson
Frida Olsson is the project manager for a program providing local affiliate services with LPPV staff to a pharmaceutical company covering 80 countries. Before joining ICON in 2016, she was working as the UK and Ireland LPPV for 7 years at a local affiliate.