Consulting services to meet GxP CSV requirements
for Pharmaceuticals and Medical devices

NEWS

NEWS

FDA: [Japanese Translate Version] Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: DRAFT GUIDANCE 7-Jan-2025] Total page-64, upload [REFERENCE] Page

Vol.7

No.4

(日本語訳版)「AI:人工知能対応医療機器ソフトウェア機能: ライフサイクル管理および販売許可申請に関する推奨ガイダンス(ドラフト)2025年1月7日(全68ページ)」[REFERENCE] Upload (Japanese Translate Version) FDA: Artificial Intelligence-Enabled Device Software Functions: Lif
…続きを読む

FDA: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. Document issued on 7-Jan-2025.

Vol.7

No.3

FDA : AI 人工知能対応デバイスソフトウェア機能:ライフサイクル管理とマーケティング提出の推奨事項」の [ドラフトガイダンス: 7-Jan-2025] ご紹介。 FDA: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recom
…続きを読む

AI_ChatGPT

HiroPharmaConsulting® Co., Ltd. will start providing the AI-PV Consulting Service in CY2025/1Q for "PV with AI: Validation Method for Pharmacovigilance System for GVP (Patent pending: Japanese Patent Application 2024-123456)."

Vol.7

No.2

AI機能を搭載した PV: Pharmacovigilance Systemの「GVPバリデーション手法(特許出願中・審査請求中:)」に対応したコンサルティングサービスのご案内です。 本案内は、最近各 PV Application Systemに搭載されてきています「AI機能:AI, ML, GenAI, LLMs and ChatGPT等」を、本番稼働後にどのように GVP/CSV Valid
…続きを読む

MHRA [Policy paper] Impact of AI on the regulation of medical products Published 30 April 2024, and (Japanese Translated Version) Webpage [REFERENCE] Uploaded.

Vol.7

No.1

MHRA Policy Paper: MHRA 「AIが医薬品規制に与える影響」 の日本語訳版を [REFERENCE]にアップロード / MHRA [Policy paper] Impact of AI on the regulation of medical products Published 30 April 2024, and (Japanese Translated Versio
…続きを読む

Letter from the European Medicines Agency (EMA) and the Commissioner of the European Medicines Agency (HMA) regarding the use of AI-LLMs and Guiding Principles (for internal EU Regulatory Authorities).

Vol.6

No.19

AI-大規模言語モデル (LLMs) 利用時の欧州『EMA: 欧州医薬品庁/ HMA: 欧州医薬品庁長官』からの指導原則(欧州規制当局内向け)提示と、EMA AI 関連レター発表 のご紹介 Letter from the European Medicines Agency (EMA) and the Commissioner of the European Medicines Agency (H
…続きを読む

FDA to Start Regulating AI, AI/ML and GenAI? (FDA Paper) : Introduce [Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP Work Together]

Vol.6

No.18

FDA で AI, AI/ML and GenAIのレギュレーション検討が本格的に始まる? (FDA Paper):「人工知能と医療製品: CBER、CDER、CDRH、and OCP がどのように連携しているか」 のご紹介 FDA to Start Regulating AI, AI/ML and GenAI? (FDA Paper) : Inroduce [Artificial Intel
…続きを読む

AI_ChatGPT

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

Vol.6

No.17

DIA Japan 2024参加報告 : AI, AI/ML and GenAI related the Luncheon Seminar by ArisGlobal on 2024/10/29 Report on Participation in DIA Japan 2024, Luncheon Seminar by ArisGlobal on 2024/10/29
…続きを読む

HIroPharmaConsulting

November 1st, 2024 marked the third(3rd) anniversary of our incorporation from November 1, 2021. To commemorate this, we renewed our [HiroPharma Webpage] as usual.

Vol.6

No.16

November 1st, 2024 marked the third(3rd) anniversary of our incorporation from November 1, 2021. To commemorate this, we renewed our [HiroPharma Webpage] as usual.
…続きを読む

AI_ChatGPT

AI Validation: Report of the World Drug Safety Congress Europe : How do you validate PV-AI capabilities?

Vol.6

No.15

AI Validation: Report of the World Drug Safety Congress Europe : How do you validate AI capabilities?
…続きを読む

NMPA

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

Vol.6

No.14

中国 NMPA :ICH E2B(R3) Regional CN-Item Tagの一部更新(日本語版・オリジナル中国語版)のお知らせ。「附件4-个例安全性报告元素说明」 China NMPA: ICH E2B (R3) Regional CN-Item Tag partially updated. Appendix 4-Example Safety Report Elements (Japa
…続きを読む

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]

Vol.6

No.13

中国 NMPA/CDE (No.5) : 医薬品臨床試験中の安全性データ緊急報告に関するFAQ:日本語翻訳版・オリジナル中国語版アップロードのお知らせ China NMPA/CDE (No. 5): FAQ on Expedited Reporting of Safety Data during Clinical Trials: Japanese Translation and Original
…続きを読む

AI_ChatGPT

Overview of the regulatory AI/ML Regulation and Guideline/Standard regarding the application of CSV Policy/Method in the GxP Application System

Vol.6

No.12

alidation of AI/ML: Artificial Intelligence and Machine Learning: 人工知能と機械学習を利用時のバリデーションについて (概要紹介) 「AI/ML : Artificial Intelligence and Machine Learning: 人工知能と機械学習を利用時のバリデーションについて」 GxP Application Sy
…続きを読む

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

Vol.6

No.11

中国 NMPA/CDE (No.3) : 薬品審査評価センター薬物臨床試験期間安全情報評価とリスク管理業務手順(試行):日本語翻訳版・オリジナル中国語版アップロードのお知らせ Evaluation and Risk Management Procedures for Drug Clinical Trials (Trial) : Japanese Translation & original C
…続きを読む

NMPA

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

Vol.6

No.10

今回は、中国の規制当局 NMPA/ CDEから発出されています、「新薬ベネフィット-リスク評価技術指導原則」のガイドラインの「日本語訳翻訳版」を作成しましたのでご紹介・ご提示を致します。 New Drug Benefit-Risk Assessment Technical Guidance Principles>>: Japanese Translation & original Chinese
…続きを読む

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

Vol.6

No.9

中国 NMPA/CDE : 臨床・治験における安全性情報の取扱いの指導原則ガイドライン:日本語翻訳版・オリジナル中国語版アップロードのお知らせ Chinese NMPA/CDE: Guideline for the Handling of Safety Information in Clinical and Clinical Trials: Japanese Translation Notif
…続きを読む

ANVISA

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

Vol.6

No.8

ブラジル ANVISA における医療機器登録保有者による現地活動の必須実施要件および通知: 日・英翻訳版・参照原本ポルトガル語アップのお知らせ。 (Japanese/ English: Portuguese Original) : ANVISA Establishes mandatory execution and notification of field actions by medical
…続きを読む