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-22 |