Module 1 2021

28/06/2021

Preliminary PMDA Consultation

Quick (2 weeks pre-notice) Preparation for the formal consultation Free Only in Japanese language In general short about 20-30 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

25

Formal PMDA Consultation

Takes 2h Minutes prepared by PMDA and reviewed by Sponsor Legally binding Meeting held in Japanese language with JP/Eng. and Eng./JP Interpreters 2 months pre-notice Relatively expensive (depending on the type of consultation) Labour - intensive

Distribution to third parties is not allowed

26

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