A book co-authored by A2Healthcare employees was published in 〈ICH E6(R3)/E8(R1)/Revised GCP Guidance〉 QMS Implementation (Issue Management and CAPA Development) in Clinical Trials/Clinical Research and Utilization of QbD in Study Design(updated on 9/20)
News
A book co-authored by A2Healthcare employees was published in <ICH E6(R3)/E8(R1)/Revised GCP Guidance> QMS Implementation (Issue Management and CAPA Development) in Clinical Trials/Clinical Research and Utilization of QbD in Study Design published by Science & technology Co.,Ltd. on Wednesday,September 11,2024.
【Title】
2nd part, Chapter1,Section 3
Quality tolerance limits (QTLs) settings and parameter examples
3rd part, Chapter1,Section 2
The practice of Risk-Based Approach (RBA) in the implementation phase of clinical trials/clinical research
【Co-author】
Hidenobu Kondo（Clinical Operation Steering Department Centralized Monitoring Section ）