日本語訳

CIOMS WG XIV “Artificial Intelligence in Pharmacovigilance 2025“ Japanese version (Official)

• 2026.06.28

Pressrelease：HiroPharmaConsulting® Launches AI-PV POC/FS Consulting Service Supporting AI Use in Intake & Triage and Literature Screening from a Human Oversight Perspective

• HiroPharmaConsulting®
• 2026.05.19

Pressrelease：HiroPharmaConsulting® Launches AI-PV POC/FS Consulting Service Supporting AI Use in Intake & Triage and Literature Screening from a Human Oversight Perspective

• HiroPharmaConsulting®
• 2026.05.04

HPC_HPVM Technical Whitepaper #2（Japanese） AI-PV HiroPharma Validation Method (HPVM) — Regulatory-Ready Human-Based Validation Framework for AI-Enabled PV Systems - #2 | Updated: 22-Dec-2025

• 2025.12.22

AI-PV HiroPharma Validation Method（HPVM）- HPVM Core Concept -

• 2025.12.15

HPVM (AI-PV HiroPharma Validation Method): Official Licensing Program Launched

• 2025.12.13

HPC_HPVM Whitepaper v2.0（English） AI-PV HiroPharma Validation Method (HPVM) — Regulatory-Ready Human-Based Validation Framework for AI-Enabled PV Systems — Version 2.0 | Updated: 05-Dec-2025

• 2025.12.13

Press release 3-Dec-2025: A new standard for AI-era PV validation: HPVM patented

• 2025.12.03

(Japanese Version) Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan_Japanese

• 2025.06.05

日本語訳版）FDA 「医薬品および生物学的製剤の規制判断を支援する人工知能（AI）の使用に関する考察」　（ドラフト）：　FDA [Considerations for the Use of Artificial Intelligence to Support Regulatory Decision/Making for Drug and Biological Products. Draft Guidance for Industry and Other Interested Parties]

• 2025.05.17