The Road to Pharmacovigilance Outsourcing Guidance
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REVIEW
The Road to Pharmacovigilance Outsourcing Guidance Bert van Leeuwen1 · Brian Edwards2 Received: 21 July 2020 / Accepted: 9 October 2020 © The Drug Information Association, Inc 2020
Abstract In this publication, the authors, having gained several decades of experience in Pharmacovigilance departments, both in pharmaceutical companies as well as in service providers companies, describe the reason why and the way how a guideline for outsourcing was created. While outsourcing in pharmacovigilance has become the rule rather than the exception in the last decade, a consensus guideline, based on best practice, appears to be missing. A group of committed professionals have given their time and knowledge to an iterative process of writing and reviewing drafts of such a guideline. One of the authors was closely involved with the writing as well as presenting the draft guidance at conferences. The other author was managing the process, including discussions, periodically reviewing the result, as well as responding to the reviewers’ comments. In this publication, a high-level overview of the guideline is provided. The key message is that outsourcing in PV requires both a detailed preparation, including risk assessments of the various elements, as well as close contact with the service provider. Keywords Pharmacovigilance/PV · Outsourcing
Benefits and Challenges of New Pharmacovigilance Requirements The implementation of the EU Guidelines on Good Pharmacovigilance Practices (GVPs), aiming to promote the protection of public health [1], has brought major changes in the pharmacovigilance systems of all pharmaceutical companies who wish to market medicines in the EU. However, despite the large amount of detailed pharmacovigilance regulations and guidelines, some topics suffer from a lack of guidance on best practices. Pharmacovigilance outsourcing is an example of such a topic: over the last decade it has become, from an exception, almost the default way to operate (e.g. in case processing), thereby also raising its profile for regulatory authorities. The Medicines and Healthcare Products Regulatory Agency (MHRA) has pointed out that outsourcing is an aspect on which to focus during inspections and it has identified the areas that could be problematic for Marketing Authorisation Holders and Service Providers [2]. In * Bert van Leeuwen [email protected] 1
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Pharmacovigilance & Drug Safety, NDA Regulatory Science Ltd, Leatherhead, Surrey, UK
2
addition, they have highlighted that the interface between the client and the vendor is critical to achieve compliance [3]. Articles describing the principles of pharmacovigilance outsourcing have been published [4, 5], but a consensus guideline, describing all the steps, principles, and points to consider for this topic, is missing. This is not surprising since legal requirements for innovative work practices take a long time to be implemented. Guidelines derived from these requirements
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