Simultaneous Global New Drug Development

1. General Introduction of E17. 2. New Principles in Global development using ICH E 17 guideline. 3. Consideration of "Ethnic Factors" as Defined in ICH E5 for Drug Development and Application in ICH E17 Guidelines for Conduct of Multiregional Clinical Trials (MRCT). 4. Pooling Strategy. 5. Overall sample size and allocation to regions. 6. Consistency Evaluation in MRCTs. 7. Implementation of the ICH E17 guideline in Japan. 8. ICH E17 and MRCT: Implementation and Regulatory Perspective in China. 9. Lessons Learned from Actual Multi-regional Clinical Trials with Signals of Treatment Effect Heterogeneity. 10. Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology. 11. Analysis Models for Multi-regional Clinical Trials. 12. Utilization of Robust Estimates of Treatment Effects via Semi-Parametric Models in MRCT. 13. Hierarchical Linear Models for Multi-Regional Clinical Trials. 14. Local Treatment Effect Estimation by Borrowing Information from Similar Regions in Multi-Regional Clinical Trials. 15. Global Drug Development: Multi-Regional Clinical Trials (MRCTs) - China's Pursuit. 16. Statistical considerations in MRCT design and analysis. 17. Multiple Endpoints in Multiregional Clinical Trials. 18. Multiregional Clinical Trials with Heterogeneous Regional and Treatment Effects. 19. Regional sample size calculation in multiregional equivalence and non-inferiority trials

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• Farmácia / receituário
• Farmacologia
• Probabilidade e Estatística
• Pesquisa médica
• Epidemiologia e estatística médica

biostatistics methods;regulatory science;clinical trial design;pharmacometrics;statistical modeling;drug approval process;advanced multiregional clinical trial analysis