| 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. Release white paper to clearly describe PMDA specific requirements, best practice and suggestion of improvements 2. Make a presentation about tips of eData submission to PMDA in Japanese/global Webinar, SDE or Annual conference |
| Project Leads | |
|---|---|
| Kazuki Fukuzawa | kazuki.fukuzawa@astrazeneca.com |
| Koichi Yamaguchi | |
| Takashi Kitahara | takashi.kitahara@novartis.com |
| Shinichi Hotta | |
| Yasuhiro Iijima | |
| Yoshiko Kitagawa |