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ICH-E6(ICH-GCP) の動向・ 改訂のインパクト

JPMA ICH-E6 Project ICH-E6(ICH-GCP) RBM 2016 3 31 JPMA ICH-E6 Project ICH-E6 R2) Step 2b JPMA / 1 JPMA ICH-E6 Project ICH 1. ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use EU International Council for Harmonization of Technical Requirements for Pharmaceuticals for human use 2. 1960 1970 1990 4 6 ICH PMDA Web ICH EU 2 JPMA ICH-E6 Project 4.

JPMA ICH-E6 Project ICH-E6(ICH-GCP) の動向・ 改訂のインパクト 日本製薬工業協会 医薬品評価委員会 臨床評価部会

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Transcription of ICH-E6(ICH-GCP) の動向・ 改訂のインパクト

1 JPMA ICH-E6 Project ICH-E6(ICH-GCP) RBM 2016 3 31 JPMA ICH-E6 Project ICH-E6 R2) Step 2b JPMA / 1 JPMA ICH-E6 Project ICH 1. ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use EU International Council for Harmonization of Technical Requirements for Pharmaceuticals for human use 2. 1960 1970 1990 4 6 ICH PMDA Web ICH EU 2 JPMA ICH-E6 Project 4.

2 PMDA Web ICH EU 15 CRC 3 JPMA ICH-E6 Project ICH-E6(R2) ICH-E6 Step 2b 4 JPMA ICH-E6 Project * 1 Addendum Introduction, , , , , , , , , , , , , , , , , , , (b), (h), , (e), , , 26 *: Technical Document 5 JPMA ICH-E6 Project 2 INTRODUCTION Risk based quality management Risk-based monitoring / centralized monitoring Electronic records / essential documents 6 JPMA ICH-E6 Project 3 Glossary Addendum Certified Copy Monitoring Plan Monitoring Report* Validation of computerized System Monitoring Report Original Document centralized monitoring 7 JPMA ICH-E6 Project 4 PRINCIPLES OF ICH GCP 8 JPMA ICH-E6 Project 5-1 SPONSOR Quality Management quality management system Risk Based Approach 9 JPMA ICH-E6 Project 5-2 SPONSOR Risk Based Approach Risk Based Approach 14 ICH Quality (Q)

3 9 Guidelines Quality Risk Management EMA, Reflection Paper on Risk-Based Quality Management in Clinical Trials, 2013 JPMA ICH-E6 Project 5-3 SPONSOR Critical Process and Data Identification Risk identification Study Risk Evaluation Risk Control Risk Communication Risk Review Risk Reporting CSR / 11 JPMA ICH-E6 Project 5-4 12 Risk Based QM / / Issue Risk based QM PDCA JPMA ICH-E6 Project 5-5 Critical Process and Data Identification Risk identification Risk Evaluation 13 < Action Plan > / / / /

4 Risk Based Approach JPMA ICH-E6 Project 5-6 Risk Evaluation Risk Control 14 < > / / EDC/Labo Data On-site IT EDC IWRS Fax / Risk Based Approach JPMA ICH-E6 Project 5-7 Risk Communication Risk Review Risk Reporting 15 < Plan > Risk On-site / / Issue Issue On-site Centralized Action Plan CSR Risk Risk Based Approach JPMA ICH-E6 Project 6 SPONSOR Contract Research Organization (CRO) CRO 16 JPMA ICH-E6 Project 7-1 SPONSOR Monitoring / On-site Monitoring Centralized Monitoring Monitoring / 17 JPMA ICH-E6 Project 7-2 SPONSOR Centralized Monitoring 18 JPMA ICH-E6 Project 7-3 SPONSOR Centralized Monitoring (a) (b) (c) (d) (e) 19 JPMA ICH-E6 Project 7-4 SPONSOR Monitoring Plan Centralized monitoring On-site monitoring 20 JPMA ICH-E6 Project 2016 1 2016 2 5 2016 6 2016 11 3 Web Conference 4 ICHEWG (EU)

5 Step 4 ICH-GCP(R2) 21 JPMA ICH-E6 Project Quality Management System, Risk Review, Centralized Monitoring documentation 22 ICH-GCP JPMA ICH-E6 Project Quality Quality GCP QMS GCP 4 7 21 23 26 23 JPMA ICH-E6 Project GCP / IT 24 JPMA ICH-E6 Project QMS 25 Risk Based QM / / Issue Risk based QM Issue Management Process PDCA

6 <PDCA > Safety Information Issue Key Parameter Documentation System/ Management <System> Plan Policy Resource Parameter IT System SOP/ Manual/ Instruction Training/ Record Committee <Records> Reports Results/ Data Form Documents E-Data JPMA ICH-E6 Project JPMA (1) JPMA Step 2b Technical Document 1. Technical Document / ICH E6 ICH-E6 26 JPMA ICH-E6 Project JPMA (2) ICH-E6 E6 Quality Management System QMS Risk Based Approach Risk Serious Breach of the trial or GCP 27 JPMA ICH-E6 Project JPMA Risk Goal Gap 28 JPMA ICH-E6 Project


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