Drug Evaluation Committee ICH-E6(R3) Educational Video
Clinical Evaluation Subcommittee
KT-1, Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, has created an Explanation video to promote understanding of ICH-E6 (R3).
- In Video 1, "Efforts Toward Domestic Implementation of ICH-E6 (R3) - Changing the Mindset -," as part of efforts to change the mindset of those involved in clinical trials, we will discuss the ICH-E6 (R3) proposed in ICH-E6 (R3), taking into account the current situation in Japan. （Explanation of the new approach to clinical trials proposed in ICH-E6 (R3) and its implementation methods, taking into account the current situation in Japan.
- Video 2, "Case Study of Quality by Design - Based on a Familiar Theme -" takes restaurant selection as its subject,
- Video 3 "Case Study of Quality by Design - Based on an Actual Clinical Trial" uses a Phase 3 trial as a case study to provide a concrete understanding of the concept based on ICH-E6 (R3), respectively.
This video is mainly intended for those who are involved in monitoring and Quality Management/Quality Assurance, but we hope that all parties involved in clinical trials will view it.
- Video 1 "Efforts toward Domestic Implementation of ICH-E6 (R3) - Changing the Mindset -" Section 1
- Video 1 "ICH-E6 (R3) Implementation in Japan - Changing Mindsets -" Section 2
- Video 1 "Efforts toward Domestic Implementation of ICH-E6 (R3) - Changing Mindsets -" Section 3
- Video 2 "Case Study on Quality by Design - Based on a Familiar Theme
- Video 3 "Case Study on Quality by Design - Based on a Clinical Trial Example