Abstract
Possibilities of regulatory information management systems implementation together with other technological solutions to ensure data continuity and integrity as a prerequisite for the implementation of a risk management system in pharmaceutical data management are discussed in this article. The creation of an effective information generation process at the lifecycle stages of the pharmaceutical product is described. Regarding the needs of initial creation and making changes to the registration documentation or the implementation of pharmacovigilance, it is also necessary to ensure the continuity and integrity of information relating to such a critical component of the public health system as medicines. Major functions of regulatory information management systems are listed in coordinance with electronic data capture necessities in clinical trials and further pharmaceutical product dossier creation. Also, the reasons for integration with electronic medical records are presented. On the side of essential data infrastructure creation, major key points are listed, such as virtual servers, disk arrays, and replication technologies.
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Koshechkin, K., Lebedev, G., Tikhonova, J. (2020). Regulatory Information Management Systems, as a Means for Ensuring the Pharmaceutical Data Continuity and Risk Management. In: Czarnowski, I., Howlett, R., Jain, L. (eds) Intelligent Decision Technologies 2019. Smart Innovation, Systems and Technologies, vol 142. Springer, Singapore. https://doi.org/10.1007/978-981-13-8311-3_23
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DOI: https://doi.org/10.1007/978-981-13-8311-3_23
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