SeltaSquare and Oracle Jointly Publish Insights on AI & Machine Learning-Based 'Predictive Pharmacovigilance'
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SeltaSquare CEO Shin Min-kyung and Christopher P. Boone, PhD, of Oracle Health & Life Sciences — a global leader in pharmacovigilance systems — have jointly published their insights through the international scientific media outlet R&D World, addressing the importance of an AI and machine learning-based predictive PV framework and the future direction of the industry.
Both parties agreed that while traditional PV systems have been primarily reactive — focused on collecting and analyzing individual adverse event cases — the field must evolve toward a framework centered on AI-driven early signal detection and risk prediction. They emphasized in particular that, in an environment where large volumes of unstructured data such as electronic medical records (EMR) and real-world data (RWD) are rapidly growing, conventional case-collection approaches alone are insufficient for effective safety management.
The article also highlighted that AI technology is advancing beyond simple task automation toward early identification of safety risks, and is increasingly positioned to support regulatory response and decision-making. The authors explained that natural language processing (NLP) can be used to structure unstructured data from medical records, literature, and patient reports, while machine learning-based analysis enables more sophisticated detection of potential safety signals.
The piece further underscored the growing importance of Explainable AI (XAI) in the regulated industry. The authors argued that beyond generating outputs, AI systems must be able to explain the process and rationale behind those outputs — a prerequisite for practical application in safety assessments and regulatory proceedings.
SeltaSquare CEO Shin Min-kyung stated, "This article is meaningful in that it allowed us to share a common awareness of challenges and a technical perspective on the future of AI-based PV with the global industry. We will continue to contribute to the advancement of global-standard safety management systems grounded in AI and PV expertise, and we plan to accelerate our expansion into international markets."
Original Article: 셀타스퀘어-오라클, AI&머신러닝 기반 '예측형 약물감시' 공동 인사이트 발표
