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 Introduction

EU GVP Module 1 Quality System

EU GVP Module 2 System Master File

EU GVP Module 3 PV Inspection

EU GVP Module 4 PV Audit

EU GVP Module 5 Risk Management System

EU GVP Module 6 Management and Reporting of Adverse Reactions to Medicinal Products

EU GVP Module 7 PSUR

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

Copyright(c) 2011 Pro-Active Consulting. All Rights Reserved.