The Road to Pharmacovigilance Outsourcing Guidance.

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 One of the authors was closely involved with the writing as well as presenting the draft guidance at conferences.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. [ABSTRACT FROM AUTHOR]

Copyright of Therapeutic Innovation & Regulatory Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)