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.
2026.05.26Vol.9 No.7 EMA EMA publishes GVP Module VII PSUR Explanatory Note Rev.4: clearer expectations for scientific accountability in PSURs
2026.05.25Vol.9 No.6 AI HiroPharmaConsulting, Starsphere to Collaborate on POC/FS Support for AI-PV. Combining Knowledge from PV, Clinical, GxP/CSV, and DX to Support Life Science Companies in Considering AI Utilization
2026.05.23Vol.9 No.5 AI EU Draft Guidelines on High-risk AI Classification: Practical Implications for PV and AI-PV
2026.05.07Vol.9 No.4 FDA FDA implemented the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines.
2026.05.04Vol.9 No.3 AI HiroPharmaConsulting® Launches AI-PV POC/FS Consulting Service Supporting AI Use in Intake & Triage and Literature Screening from a Human Oversight Perspective
2026.04.24Vol.9 No.2 FDA FDA Warning Letter 320-26-58 "Indications of Inappropriate Use of AI" and Points for MAH to Caution
2026.01.06Vol.9 No.1 FDA ICH E2B (R3) ICSR Reporting for the FDA will become a mandatory requirement as of April 1, 2026
2025.12.23Vol.8 No.12 AI Announcement of a press release and technical white paper on the officially registered HPVM patent.
