Why outsourcing pharmacovigilance makes sense at an affiliate level
About this webinar
Discover an informative webinar delving into pharmacovigilance outsourcing and how an outsourced affiliate model can provide access to skilled resources with local expertise. In the past, the primary role of a pharmaceutical company’s affiliate office was to liaise with local health authorities. However, with the harmonization and globalization 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.
This webinar explores some of the challenges that marketing authorization holders (MAH) can face with local pharmacovigilance activities. The featured speakers will discuss how an outsourced affiliate model can provide access to skilled resources with local expertise providing scalability, transparency and the standardization 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
Join this webinar to gain insights into pharmacovigilance outsourcing and the potential challenges associated with local pharmacovigilance activities.
Who should attend
- Pharmacovigilance
- Regulatory
- Medical
- Clinical operations
What you will learn
- 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
Featured Speakers
Andrew Purchase
Andrew Purchase has over 17 years of industry experience, holding positions within big pharma and clinical research organizations. As Director of Pharmacovigilance Specialised Services at ICON, Andrew leads a team of Safety Scientists, many of whom serve as Local Persons for Pharmacovigilance.
Andrew oversees the build-out of ICON’s 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 worked as the UK and Ireland LPPV for seven years at a local affiliate.
Partner for this event
ICON
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.
With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.
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