株式会社ヒロファーマコンサルティング®ロゴ

JP

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

REFERENCE

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  • (Japanese Translate Version) : 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 Draft Guidance for Industry and Other Interested Parties]　

    （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 Draft Guidance for Industry and Other Interested Parties]　

  • FDA : Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (Draft) , Draft Guidance for Industry and Other Interested Parties/ Docket Number:FDA-2024-D-4689

    FDA : Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (Draft) , Draft Guidance for Industry and Other Interested Parties/ Docket Number:FDA-2024-D-4689

  • India : CDSCO: Central Drugs Standard Control Organization: [Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products Version: 2.0]

    India 「インド規制当局：中央医薬品基準管理機構（CDSCO: Central Drugs Standard Control Organization）」[Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products Version: 2.0]

  • (Japanese Translate Version) EMA: “Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle” 11-Sep-2024

    EMA: European Medicines Agency (欧州医薬品庁)から報告されています、AI関連のリフレクション・ペーパに関しての概要紹介と、その「日本語訳版」を作成して HiroPharma [REFERENCE] にアップしましたのでお知らせいたします。

  • (Japanese Version) [FDA: DHAC Executive Summary - Total Product Lifecycle Considerations for GenAl Devices: 20-21 Nov-2024]

    （日本語訳版）FDA: DHAC Executive Summary -「GenAl対応デバイス製品トータルライフサイクルに関する考慮事項 20-21 Nov-2024 : (Japanese Version) [FDA: DHAC Executive Summary - Total Product Lifecycle Considerations for GenAl Devices 20-21 Nov-2024]

  • (Japanese Version) How to Validate AI in GxP Applications for Life Science Companies by FIVE Validation (in Japanese Version, translated by HiroPharmaConsulting)

    （日本語訳版）ライフサイエンス企業向けのGxPアプリケーションでAIを検証する方法：How to Validate AI in GxP Applications for Life Science Companies by FIVE Validation, (in Japanese Version, translated by HiroPharmaConsulting)

  • [Press Release 20250211] "Launch of GVP validation consulting service for evaluation of PV System introduction with AI function"

    "Launch of GVP validation consulting service for evaluation of PV System introduction with AI function". HiroPharmaConsulting® Co., Ltd. (Head Office: Osaka City, Osaka Prefecture, Representative Director: Hirotsugu Atsumaru) will start the "GVP Validation Consulting Service for PV System Installation Evaluation with AI Functions" in March 2025.

  • [Press Release 20250211] Guidance on "Validation Service at the time of (and after) introduction of AI GVP (GxP)" for Pharmaceutical and Medical Device Manufacturers planning to implement and update GVP (GxP) Systems with AI functions.

    プレスリリース 20250211 「AI機能付GVP(GxP) 対応システム」導入・更新を計画の医薬品・医療機器メーカ向「AI GVP(GxP)導入検討時（及び導入後）Validationサービス」開始のご案内 　[Guidance on "Validation Service at the time of (and after) introduction of AI GVP (GxP)" for Pharmaceutical and Medical Device Manufacturers planning to implement and update GVP (GxP) Systems with AI functions.]