知識と情報 | 国際薬事関連情報 “欧州GVPの和訳を順次掲載” "Module Ⅶ" 新規追加
2019-10-11
EU GVP Module 1 Quality System
EU GVP Module 2 System Master File
EU GVP Module 5 Risk Management System
EU GVP Module 6 Management and Reporting of Adverse Reactions to Medicinal Products
EU GVP Module 8 Post-Authorization Safety Studies
EU GVP Module 9 Signal Management
EU GVP Module 10 Additional Monitoring
EU GVP Module 15 Safety Communication
EU GVP Module 8 Addendum 1 Member States Requirements on Non-Interventional Post-Authorization Safety Studies
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