Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom

Dinnett, E., Kean, S., Tolmie, E., Ronald, E. and Gaw, A. (2013) Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom. Trials, 14(171), (doi:10.1186/1745-6215-14-171)

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Abstract

The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting. In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use. We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Ronald, Mrs Elizabeth and Kean, Ms Sharon and Dinnett, Dr Eleanor and Gaw, Dr Allan and Tolmie, Dr Elizabeth
Authors: Dinnett, E., Kean, S., Tolmie, E., Ronald, E., and Gaw, A.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Nursing and Health Care
Journal Name:Trials
Publisher:BioMed Central
ISSN:1745-6215
ISSN (Online):1745-6215
Copyright Holders:Copyright © 2013 The Authors
First Published:First published in Trials 14(171)
Publisher Policy:Reproduced under a Creative Commons License

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