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

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Consultation Strategic Considerations

- Before PMDA consultation, strategy first!

- In-depth Japan Regulatory Strategy

- must be based on careful and well-thought research and analysis - must highlight the risk(s) and the mitigation measures - must consider other jurisdictions - must recommend shortest possible routes to market - must be clear and reasonable for consultation with PMDA - must be culturally sensitive in approach and communication

Distribution to third parties is not allowed

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