Module 1 2021

28/06/2021

PMDA Consultation

• Originally (1997) Consultation with PMDA was solely focused on clinical trials, but recently the realm of consultations has expanded into various aspects of pharmaceutical medicine, regenerative medicine and medical devices. • PMDA strongly encourages drug developers to seek PMDA consultation

Distribution to third parties is not allowed

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Consultation Strategic Considerations

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

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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