株式会社ヒロファーマコンサルティング®ロゴ

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

REFERENCE

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  • (Japanese Translated Version) [Policy Paper] : [MHRA / Impact of AI on the regulation of medical products Published 30 April 2024]

    （日本語訳版）[MHRA Policy Paper]：「MHRA 英国規制当局 / AIが医薬品規制に与える影響 2024年4月30日発行」 (Japanese Translated Version) [Policy Paper] : [MHRA / Impact of AI on the regulation of medical products Published 30 April 2024]

  • [Japanese version] Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, Mar. 2024

    （日本語訳版）　[FDA Paper] ：「人工知能と医療製品: CBER、CDER、CDRH、OCP がどのように連携しているか」Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, Mar. 2024

  • (Japanese Translated Version) China NMPA/CDE (No. 5): FAQ on Expedited Reporting of Safety Data during Clinical Trials: Japanese Translation and Original Chinese Version Uploaded

    （日本語訳版）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「Q&A(s)」　China NMPA/CDE (No. 5): FAQ on Expedited Reporting of Safety Data during Clinical Trials: Japanese Translation and Original Chinese Version Uploaded

  • Chinese original NMPA/CDE (No. 5): FAQ on Expedited Reporting of Safety Data during Clinical Trials: Japanese Translation and Original Chinese Version Uploaded

    （中国語版オリジナル）NMPA/CDE 5. 药物临床试验期间安全性数据快速报告常见问答（2.0版）（2023年第17号）Chinese original NMPA/CDE (No. 5): FAQ on Expedited Reporting of Safety Data during Clinical Trials: Japanese Translation and Original Chinese Version Uploaded

  • (Japanese translation) NMPA/CDE 4.Evaluation and Risk Management Procedures for Drug Clinical Trials (Trial)

    NMPA/CDE 4.药品审评中心药物临床试验期间安全信息评估与风险管理工作程序（试行）

  • (Chinese original) NMPA/CDE : 4. Evaluation and Risk Management Procedures for Drug Clinical Trials (Trial)

    NMPA/CDE 4. 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)

  • (J) New Drug Benefit-Risk Assessment Technical Guidance Principles

    3. 新薬ベネフィット-リスク評価技術指導原則_Japanese　（新药获益-风险评估技术指导原则）

  • (C) New Drug Benefit-Risk Assessment Technical Guidance Principles

    3. 新药获益-风险评估技术指导原则 （新薬利益-リスク評価技術指導原則）