Module 5 Presentations

18/07/2024

Presentation Outline

Market Dynamics

Drug Development Strategy

PMDA Consultation Strategy

Clinical Trials Strategy

Communication Strategy

Distribution to third parties is not allowed

31

Clinical Trials: Japan vs Europe

Parallel Regulatory-EC Approval

Regulatory Approval

EC Approval

Sequential Regulatory-EC Approval

Regulatory Approval

EC Approval

Distribution to third parties is not allowed

32

16