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REFERENCE
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（中・日・英語版）3_Standards and Procedures for Expedited Reporting of Safety Data during Drug Clinical Trials_C_J_E
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ICH E2B(R3) Core Data Elements/ Regional Elements (FDA/NMPA/MFDS/EMA/PMDA) and Business Rules ver.7.00 (updated 6-Feb-2023)
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（日本語訳版）Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan_Japanese
DOWNLOAD参考情報・会社案内・パンフレット
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（中・日・英語版）3_Standards and Procedures for Expedited Reporting of Safety Data during Drug Clinical Trials_C_J_E
（中・日・英語版）3_Standards and Procedures for Expedited Reporting of Safety Data during Drug Clinical Trials_C_J_E
-
ICH E2B(R3) Core Data Elements/ Regional Elements (FDA/NMPA/MFDS/EMA/PMDA) and Business Rules ver.7.00 (updated 6-Feb-2023)
ICH E2B(R3) Core Data Elements/ Regional Elements (FDA/NMPA/MFDS/EMA/PMDA) and Business Rules ver.7.00 (updated 6-Feb-2023)
-
（日本語訳版）Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan_Japanese
（日本語訳版）Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan_Japanese