SeltaSquare

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SeltaSquare (CEO: Shin Min-kyung) announced on the 2nd that it recently hosted a company-led seminar on the topic of "PV Audit & Inspection" at the Clinical Education Center of the Korea National Enterprise for Clinical Trials (KoNECT).

The seminar was designed for practitioners with two or more years of experience in the pharmacovigilance field. In the session titled "PV Inspection Trends," CEO Shin Min-kyung provided an overview of the audit approaches and processes employed by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Korea's Ministry of Food and Drug Safety, along with common challenges encountered in this area and recommended responses. In the following session on "Preparing for and Responding to Audits and Inspections," Director Han Gyeong-hee of SeltaSquare presented a concrete action plan covering PV audit preparation, execution, and post-audit procedures.

A SeltaSquare representative noted that approximately 100 PV professionals attended the training, and that the event received a strong response for sharing global trends alongside detailed practical guidance.

CEO Shin Min-kyung remarked: "It was a meaningful occasion to share the know-how we have accumulated over many years of conducting PV work at domestic and international pharmaceutical companies. We plan to offer an advanced course in the second half of the year." She also stated that the company would actively incorporate expert feedback into its PVQA service and AI-based solutions, and added that through its global partnership with Oracle for Safety DB Oracle Argus, SeltaSquare aims to build a practical system accessible to users overseas as well.

SeltaSquare is a company providing AI and DX-based pharmacovigilance solutions, holding 4 domestic and international patents in the AI field with an additional 12 applications filed.

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