SeltaSquare Presents RWD-Based Pharmacovigilance Strategy at KIC 2025 Sponsor Session
페이지 정보
본문
SeltaSquare (CEO: Shin Min-kyung), an AI-based Safety Data specialist company, announced on the 1st that it drew significant attention at the 2025 KoNECT-MOHW International Conference (KIC 2025), held from September 22 to 24 at Lotte Hotel Seoul, where it unveiled its post-marketing pharmacovigilance strategy and service vision based on Real-World Data (RWD).
At the KIC 2025 Sponsor Session, Lee Hye-jeong, Head of SeltaSquare's Clinical Strategy Division, delivered a presentation titled "Advancing Post-Marketing Surveillance in APAC and RWD-Driven Safety Evaluation." The session drew considerable interest from domestic and international attendees, as it covered the latest draft direction of the ICH M14 guideline alongside practical RWD-based evaluation case studies and real-world implementation strategies.
Through this presentation, SeltaSquare highlighted its proactive surveillance-based service framework centered on RMP OneScope™, along with its AI-based data standardization technology, and disclosed its strategy for leveraging post-marketing drug safety surveillance data. The framework represents a proactive response to a broader market shift — moving away from conventional passive surveillance centered on Post-Marketing Surveillance (PMS) studies toward a more dynamic and flexible evaluation system built around Risk Management Plans (RMP) and Real-World Evidence (RWE).
Lee Hye-jeong stated: "In the context of evolving regulatory environments and the expanding use of RWD, pharmacovigilance activities within RMP are an essential component of effective safety management. Based on SeltaSquare's expertise in pharmacovigilance, and leveraging digital and AI technologies, we are able to deliver integrated drug safety surveillance — not only through RWD studies conducted in accordance with international standards, but also through non-interventional studies such as PMS and observational studies."
Meanwhile, SeltaSquare recently established a Clinical Strategy Division and Data Center, further solidifying the potential for practical expansion of its RWD-based pharmacovigilance strategy. SeltaSquare's Clinical Strategy Division is leading the evolving landscape across APAC and beyond, providing RMP-based drug safety surveillance research services as an execution-ready partner capable of translating insights into actual safety evidence generation.
Read the Original Articles:
