The Road to Pharmacovigilance Outsourcing Guidance

In this great article published in the October 2020 issue of Therapeutic Innovation & Regulatory Science, Bert van Leeuwen and NDA’s Pharmacovigilance expert Dr. Brian Edwards discuss “The Road to Pharmacovigilance Outsourcing Guidance”.


Pharmacovigilance cannot be performed in isolation. In fact, there is a wide variety of tasks that can be outsourced in pharmacovigilance which requires detailed preparation, for the client as well as the vendor.

Brian Edwards

This review article, co-authored by NDA’s Brian Edwards, invites us behind the scenes of the work on well-needed consensus guidelines regarding the outsourcing of pharmacovigilance services, describing the step-by-step process starting from the decision to outsource up to how to ensure a successful outcome.

This article describes the way Guidance for Pharmacovigilance Outsourcing was developed. The intention is to support clients and vendors in understanding the content and thereby also being able to navigate the complexity of involving expert consultants in a constructive pharmacovigilance process.

While the Guidance for Pharmacovigilance Outsourcing aims to facilitate smooth and successful outsourcing, without a uniform, rigid framework, this article provides transparency in the thought process behind the guidelines, explaining a perhaps overwhelming number of initial questions. Why is the sponsor/service provider interface immensely important to get exactly right? How does this approach to outline guidelines circumvent the pitfalls that commonly arise in such a process? How did the authors avoid common biases when creating guidance documentation?

Outsourcing the safety of your product during development is a matter of deep trust. It is not the time for excessive expectations or vague specifications of requirements. To get it right you must know what you need and what to ask for. You also need to know why these things are essential and this paper provides the explanation.

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van Leeuwen, B., Edwards, B. The Road to Pharmacovigilance Outsourcing Guidance. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00229-w