Update on Korea China Japan Tripartite Clinical Trial ... - Apec-ahc.org

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Roadmap to promote MRCT Goal:To facilitate MRCTs and acceptance of MRCT results for drug review by regulatory authorities in APEC regions Overview: Evaluate current practices relative to international best practices Establish common understanding regarding the following key issues and other issues within APEC region under the auspices of LSIF. [Key Issues] - Implementation of ICH E5 guideline - Study design of MRCT - Operational/Regulatory procedure to facilitate MRCT efficiently - Cooperative regulatory approach to facilitate MRCTs on diseases prevalent in subregions of APEC. Implement training for those involved in MRCT Develop necessary items for Training/Workshop to promote MRCT - APEC economies share best practices - MRCTWS as well as each economy considers developing training curricula Issue recommendation on regulatory harmonization regarding MRCT RHSC will support the activities and development of recommendation for next step.
Asia’s Role in Global Drug Development EU East Asia Japan ASIA ASEAN APEC North America USA Canada
Page 1 and 2: Update on Korea Ch
Page 3 and 4: Trends of MRCTs including Japan (2/
Page 5 and 6: ILD on Temsirolimus Clinical Trial
Page 7 and 8: Japan’s Activities on Ethnic Fact
Page 9 and 10: Summary of PK data analysis Ethnic
Page 11 and 12: Relative AUC difference Moxifloxaci
Page 13 and 14: APEC LSIF (Life Science Innovation
Page 15: 1. Overall Recommendations A) MRCTW
Page 19 and 20: 国際共同試験での日本人
Page 21 and 22: Ethnic Difference in Pharmacokineti
Page 23: Difference among East Asian populat

Update on Korea China Japan Tripartite Clinical Trial ... - Apec-ahc.org

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