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Development of a Real-Time Decision Support System for Regulatory Compliance and Drug Safety Management in Multinational Pharmaceutical Operations
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| Author:
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, J REVATHI, R JAYADURGA, S RATHIKA
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| Abstract:
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The increasing pace of globalization in pharmaceutical activities has enhanced the difficulty of complying with the regulatory standards and safety of drugs within the different jurisdictions. In this paper, the author will develop Real-Time Decision Support System (DSS) which will be customized governing multinational pharmaceutical companies in order to facilitate the regulatory compliance and pharmacovigilance. The suggested system unites real time data collection, cross border compliance rule mapping, and system output to safety signal detection whereupon such data can be used by regulatory and safety management teams to take action. Using artificial intelligence and rule-based engines, DSS is being dynamically configured based on the changing international regulations, eliminating the compliance risks and accelerating the necessary remedial actions. Regulatory intelligence ingestion, drug safety monitoring, real-time analytics and secure audit trails have been built into a modular architecture in the architecture to enable modular, scalable and traceable architecture. By performing simulation deployments and case-based validation of the system by references to FDA, EMA, CDSCO standards, the system showed better compliance accuracy (91.2%) and decreased safety response time in comparison with legacy systems. In addition, it works perfectly with legacy enterprise resource planning (ERP) and clinical trial management systems (CTMS) without causing disruptions when adopted. Multilingual regulatory updates and geography-specific compliance customization are other features provided by the system that are important because there might be different operations scattered geographically. The article adds a new, real-time, artificially intelligent framework that has the power to convert the static compliance checks into proactive safety management toolsets. The results imply that real-time regulatory harmonization and smart safety surveillance can imply dramatically fewer risks of adverse events and an improvement in international pharmaceutical regulation. The proposed DSS presents an architecturally scalable and outward-looking solution to the pharmaceutical entrepreneurs who prefer to have operations that are efficient and compliant with the fast-evolving global regulatory environment.
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| Keyword:
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Pharmaceutical Compliance, Drug Safety, Decision Support System, Regulatory Adherence, Pharmacovigilance, Artificial Intelligence, Global Pharmaceutical Governance
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.04.026
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| Download:
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Request For Article
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