2026.09.02Vol.9 No.19 AI 【From "AI-integrated PV" to "AI-native PV" — What Should PV Organizations Start in FY2027?】
2026.08.30Vol.9 No.18 AI Redesigning the PV Organization in the Age of AI — Will Pharmacovigilance Professionals Still Be Needed?
2026.08.15Vol.9 No.16 AI How should an MAH read an AI-PV Case Study? — Reflections on the BMS / ArisGlobal NavaX case —
2026.08.14Vol.9 No.15 AI 【Preview + Episode#1 - #6 New Series How Should Humans Be Involved with AI? — Rethinking Human Oversight】 AI is rapidly becoming part of everyday business and society. <▶ Please expand it.>
2026.08.11Vol.9 No.14 AI HPC New Series AI-PV| Chapter 4: "If an audit asks you to explain AI, what should you show?"
2026.08.11Vol.9 No.13 AI [AI-PV business] What is the difference between HITL and HOTL? Advantages/disadvantages and design methods for pharmacovigilance
2026.07.26Vol.9 No.12 AI HPC NEW Series Trailer + 6 Episodes: AI-PV: Where Do We Actually Start? 6-Questions PV Leaders and Teams Need to Answer
2026.07.24Vol.9 No.11 NEWS FLASH REPORT: Dassault Systèmes Announces Agreement to Acquire ArisGlobal : The PV Systems Market Is Moving from Standalone Products to Cross-Functional Life Sciences Platforms
2026.07.15Vol.9 No.10 FDA The U.S. Food and Drug Administration (FDA) is requesting input on patient safety associated with certain non-device software functions excluded from the medical device definition. Comments are due by August 13, 2026.
2026.07.13Vol.9 No.9 AI Introduction to CIOMS AI in PV 2025 Preprint Japanese version. CIOMS AI-PV 2025 [CIOMS AI-PV 2025: A Translator's Guide to Principles & Good Practices for AI in Pharmacovigilance
2026.06.30Vol.9 No.8 NEWS On July 1, 2026, HPC celebrated its seventh(7th) anniversary. Since its founding on July 1, 2019, as a sole proprietorship, HPC has conducted studies and support for GVP/CSV, PV system introduction support, GVP internal audits, and, in recent years, reliability assurance of PV systems equipped with AI functions.
