HiroPharmaConsulting® Co., Ltd

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?

2026.08.19Vol.9 No.17 FDA

HPC Newsletter | FDA AI-MD Regulatory Flash

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.>

2026.09.02 AI

【From "AI-integrated PV" to "AI-native PV" — What Should PV Organizations Start in FY2027?】

2026.08.30 AI

Redesigning the PV Organization in the Age of AI — Will Pharmacovigilance Professionals Still Be Needed?

2026.08.15 AI

How should an MAH read an AI-PV Case Study? — Reflections on the BMS / ArisGlobal NavaX case —

2026.08.14 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.>

2026.08.11 AI

HPC New Series AI-PV| Chapter 4: "If an audit asks you to explain AI, what should you show?"

2026.08.19 FDA

HPC Newsletter | FDA AI-MD Regulatory Flash

2026.07.15 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.

2026.05.07 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.

2026.04.24 FDA

FDA Warning Letter 320-26-58 "Indications of Inappropriate Use of AI" and Points for MAH to Caution

2026.01.06 FDA

ICH E2B (R3) ICSR Reporting for the FDA will become a mandatory requirement as of April 1, 2026

2026.07.24 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

2026.06.30 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.

2025.10.29 NEWS

[HiroPharmaConsulting] On November 1, 2025, HiroPharmaConsulting Co., Ltd. celebrated its fourth(4th) anniversary of incorporation.

2025.09.24 NEWS

Reference: Yakuji Nippo News, PV: Pharmacovigilance Special Feature Interview with HiroPharmaConsulting Co., Ltd

2025.07.01 NEWS

This time, we are pleased to announce the complete renewal and reopening of the [HiroPharma Webpage] to commemorate the 6th anniversary of HiroPharma Consulting (established on July 1, 2019).

2025.07.21 ISPE

ISPE GAMP® Guide: Artificial Intelligence was published in July 2025.

2025.05.07 ISPE

[ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) [Japanese Translation] Published: April 2025 Pages: 410]

2024.03.18 ISPE

ISPE : Machine Learning Risk and Control Framework

2022.08.24 ISPE

Published ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)

2024.11.01 DIA

Report on Participation in DIA Japan 2024, AI, AI/ML and GenAI related the Luncheon Seminar by ArisGlobal on 2024/10/29

2024.10.20 NMPA

China NMPA: ICH E2B (R3) Regional CN-Item Tag partially updated. Appendix 4-Example Safety Report Elements (Japanese translated and original Chinese)

2024.09.16 NMPA

China NMPA/CDE (No. 5): FAQ on Expedited Reporting of Safety Data during Clinical Trials: Japanese Translation and Original Chinese Version Uploaded, uploaded into HiroPhrma [REFERENCE]

2024.09.10 NMPA

NMPA/CDE (No.4) : Evaluation and Risk Management Procedures for Drug Clinical Study (Trial) : Japanese Translation & original Chinese Version upload in HiroPharma [REFERENCE] Notification

2024.08.28 NMPA

NMPA/CDE (No.3) : New Drug Benefit-Risk Assessment Technical Guidance Principles>>: Japanese Translation & original Chinese Version upload in HIroPharma [REFERENCE] Notification

2024.08.21 NMPA

NMPA/CDE (No.1 No.2) : Guideline for the Handling of Safety Information in Clinical and Clinical Trials: Japanese Translation & original Chinese Version upload in HIroPharma [REFERENCE] Notification

2024.08.06 ANVISA

(Japanese/ English: Portuguese Original) : ANVISA Establishes mandatory execution and notification of field actions by medical device registration holders in Brazil

2024.08.05 ANVISA

(Japanese/ English: refer Portuguese Original) : ANVISA Provisions regarding post-market surveillance applicable to registration holders of health product in Brazil

2023.11.18 ICH

Uploaded in the HiroPharma [REFERENCE] Page : (Japanese translated version) Pre- and post-marketing safety reports to the FDA using ICH E2B(R3) Guideline : "November 7, 2023 FDA Public Meeting Webinar Report"

2023.03.10 ICH

Reporting Individual Case Study Reports (ICSRs) to FDA Adverse event Reporting System (FAERS) Using ICH E2B R3 Standards [Webinar Document 13-Jan-2023] uploaded on REFERENCE Page

2020.02.09 ICH

FDA 3rd Public Meeting “Electronic Adverse Event Reporting to FDA (R3) Using ICH E2B (FAERS-II)”　

2022.12.14 PMDA

The English version of Q&A on Post-marketing adverse reaction reporting and Clinical Trial adverse reaction reporting in accordance with the MHLW/FDA E2B (R3) Implementation Guide (English version 24-Jun-2022) has been uploaded on the HiroPharma Reference Page.

2022.08.10 MFDS

Korea MFDS Electronic Transmission of Individual Case Safety Reports E2B(R3) Data Elements and Message Specification

2020.04.06 MFDS

Korea MFDS ICH E2B(R3) Regional Requirement Elements: Republic of Korea

2020.02.09 MFDS

Kore MFDS: Electronic Reporting Guidelines for Adverse Drug Reactions and Adverse Events

2026.09.02 GxP

【From "AI-integrated PV" to "AI-native PV" — What Should PV Organizations Start in FY2027?】

2026.08.30 GxP

Redesigning the PV Organization in the Age of AI — Will Pharmacovigilance Professionals Still Be Needed?

2026.08.15 GxP

How should an MAH read an AI-PV Case Study? — Reflections on the BMS / ArisGlobal NavaX case —

2026.08.14 GxP

【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.>

2026.08.11 GxP

HPC New Series AI-PV| Chapter 4: "If an audit asks you to explain AI, what should you show?"

2026.05.26 EMA

EMA publishes GVP Module VII PSUR Explanatory Note Rev.4: clearer expectations for scientific accountability in PSURs

2026.07.13 CIOMS

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

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