Consulting services to meet GxP CSV requirements
for Pharmaceuticals and Medical devices
REFERENCE
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(Japanese Translate Version ) : Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: DRAFT GUIDANCE 7-Jan-2025 Total Page-64
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Press Release: Start of Consulting Support for post-Production GVP Validation Methods for PV Systems with AI functions
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[Press Release] "Start of Consulting Support for post-Production GVP Validation Methods for PV Systems with AI functions"
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(Japanese Translated Version) [Policy Paper] : [MHRA / Impact of AI on the regulation of medical products Published 30 April 2024]
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[Japanese version] Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, Mar. 2024
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(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
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Chinese original NMPA/CDE (No. 5): FAQ on Expedited Reporting of Safety Data during Clinical Trials: Japanese Translation and Original Chinese Version Uploaded
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(Japanese translation) NMPA/CDE 4.Evaluation and Risk Management Procedures for Drug Clinical Trials (Trial)
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(Japanese Translate Version ) : Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: DRAFT GUIDANCE 7-Jan-2025 Total Page-64
(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64ページ)」/ (Japanese Translate Version ) : Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: DRAFT GUIDANCE 7-Jan-2025 Total Page-64
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Press Release: Start of Consulting Support for post-Production GVP Validation Methods for PV Systems with AI functions
Press Release:「AI機能実装PV System稼働後のGVPバリデーション手法のコンサルティングサポート開始」 Press Release: Start of Consulting Support for post-Production GVP Validation Methods for PV Systems with AI functions
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[Press Release] "Start of Consulting Support for post-Production GVP Validation Methods for PV Systems with AI functions"
[Press Release] "Start of Consulting Support for post-Production GVP Validation Methods for PV Systems with AI functions" 株式会社ヒロファーマコンサルティングは、「AI機能を搭載した PV: Pharmacovigilance Systemの GVP対応バリデーション手法」に対応した 「AI-PV Validationコンサルティングサービス」をCY2025年度1Qより提供を開始します。: HiroPharma [NEWS] Vol.7 NO.2、[reference] Press Release 2024/12/07参照
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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]
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(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
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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