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.
Highlights
There is a wealth of regulations concerning the obligations incumbent upon Sponsors of clinical trials [7, 8] and Marketing Authorization Holders (MAHs) for marketed medicinal products [2, 4]
Each of the technologies identified in this paper has the potential to yield efficiencies and improvements of quality for individual case safety reports (ICSRs), and in the context of aggregate reporting, signal detection, risk management, and the Quality (management) system (QMS) for the PV system
We believe that PV systems may be improved by intelligent automation
Summary
There is a wealth of regulations concerning the obligations incumbent upon Sponsors of clinical trials [7, 8] and Marketing Authorization Holders (MAHs) for marketed medicinal products [2, 4]. These obligations mandate the collection of large and growing volumes of safety data [4], with some MAHs conducting over one million transactions involving individual case safety reports (ICSRs), medication errors, product quality complaints, and exposures to medicines during pregnancy. These databases are often linked to a data warehouse and advanced tools to enable the retrieval reporting and visualization of data in support of signal detection and risk management [5, 6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
