| Project Scope |
|---|
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 |
| Project Leads | |
|---|---|
| Kazuki Fukuzawa | kazuki.fukuzawa@astrazeneca.com |
| Koichi Yamaguchi | |
| Takashi Kitahara | takashi.kitahara@novartis.com |
| Shinichi Hotta | |
| Yasuhiro Iijima | |
| Yoshiko Kitagawa |