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To raise awareness of eData submission to PMDA globally, especially focusing on PMDA specific requirements and practical challenges. To provide ideas for improvements for eData submission process/deliverables and to discuss better solution for both for PMDA and sponsor/CRO.

Objectives:

1.

Produce a white paper to clearly describe PMDA specific requirements, best practice and suggestion

for improvements

2.

Create a presentation

on tips of eData submission to PMDA

to be presented at a Webinar, SDE or

Connect