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Review
. 2020 Jul;54(4):888-899.
doi: 10.1007/s43441-019-00023-3. Epub 2019 Dec 28.

Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities

David John Lewis  1   2 , John Fraser McCallum  3
Affiliations
Review

Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities

David John Lewis et al. Ther Innov Regul Sci. 2020 Jul.

Abstract

There are significant challenges and opportunities in deploying and utilizing advanced information technology (IT) within pharmacovigilance (PV) systems and across the pharmaceutical industry. Various aspects of PV will benefit from automation (e.g., by improving standardization or increasing data quality). Several themes are developed, highlighting the challenges faced, exploring solutions, and assessing the potential for further research. Automation of the workflow for processing of individual case safety reports (ICSRs) is adopted as a use case. This involves a logical progression through a series of steps that when linked together comprise the complete work process required for the effective management of ICSRs. We recognize that the rapid development of new technologies will invariably outpace the regulations applicable to PV systems. Nevertheless, we believe that such systems may be improved by intelligent automation. It is incumbent on the owners of these systems to explore opportunities presented by new technologies with regulators in order to evaluate the applicability, design, deployment, performance, validation and maintenance of advanced technologies to ensure that the PV system continues to be fit for purpose. Proposed approaches to the validation of automated PV systems are presented. A series of definitions and a critical appraisal of important considerations are provided in the form of use cases. We summarize progress made and opportunities for the development of automation of future systems. The overall goal of automation is to provide high quality safety data in the correct format, in context, more quickly, and with less manual effort. This will improve the evidence available for scientific assessment and helps to inform and expedite decisions about the minimization of risks associated with medicines.

Keywords: Artificial intelligence; Automation; Emerging technology; Information technology; Pharmacovigilance.

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Conflict of interest statement

The authors declare no conflicts of interest. However, all authors are employees and/or stockholders of the companies with which they are affiliated.

Figures

Figure 1.
Figure 1.
Typical Process for the Management of Individual Case Safety Reports Within a Marketing Authorization Holder.
Figure 2.
Figure 2.
Conceptual Diagram Showing the Different Entities Relating to Automation in PV Systems.
See this image and copyright information in PMC

References

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