Module 5 Presentations

18/07/2024

Consultation Strategic Considerations

PMDA strongly encourages drug developers to seek PMDA consultation When you seek PMDA advice be prepared to follow it Divergence from PMDA advice should be justified For successful PMDA consultation outcomes - Strong scientific rationale - High Quality of the briefing document - Clear and scientifically sound responses to PMDA queries - Good communication with PMDA

The whole process -not only F2F meeting with PMDA- is important to obtain the most effective advice

Distribution to third parties is not allowed

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Preliminary PMDA Consultation

Quick (4 weeks pre-notice) Preparation for the formal consultation. It is highly recommended! Free Only in Japanese language (Interpreters allowed) As a rule, it takes about 20 min Limited number of participants usually 4 or 5 Not appropriate for in-depth scientific review No minutes

Distribution to third parties is not allowed

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