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.
2025.12.13Vol.8 No.9 AI HPVM (AI-PV HiroPharma Validation Method): Official Licensing Program Launched
2025.12.10Vol.8 No.8 AI CIOMS “Artificial Intelligence in Pharmacovigilance (2025)” and HPVM: From Principles to Practical Implementation
2025.11.12Vol.8 No.6 AI HiroPharmaConsulting has received an official "GxP Validation Method for PV System with AI Function (Japanese Patent Application 2024-213393)" from the Japan Patent Office.
2025.10.29Vol.8 No.5 NEWS [HiroPharmaConsulting] On November 1, 2025, HiroPharmaConsulting Co., Ltd. celebrated its fourth(4th) anniversary of incorporation.
