| 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 |
| Project Members | Organisation |
|---|---|
| Tomohiko Funai | Eli Lilly |
| Yasuhiro Iijima | Novartis |
| Eri Sakai | Novartis |
| Iori Sakakibara | Janssen |
| Noriyuki Shibayama | Janssen |
| Rie Kageyama | Sumitomo Pharma |
| Yasuhiko Ozawa | AstraZeneca |
| Hisae Yagishita | A2 Healthcare |
| Ryo Watanabe | A2 Healthcare |
| Takafumi Kamon | A2 Healthcare |
| Kayo Inushima | Biogen |
| Keita Takahashi | Chugai |
| Zhengyan Luo | Bristol Myers Squibb |
| Published Deliverables | Date |
|---|---|
| 09-June-2022 |