Project Scope |
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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 |
Project Leads | |
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Kazuki Fukuzawa | kazuki.fukuzawa@astrazeneca.com |
Koichi Yamaguchi | |
Takashi Kitahara | takashi.kitahara@novartis.com |
Shinichi Hotta | |
Yasuhiro Iijima | |
Yoshiko Kitagawa |
Project Members | Organisation |
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TomohikoFunai | Eli Lilly |
YasuhiroIijima | Novartis |
EriSakai | Novartis |
IoriSakakibara | Janssen |
NoriyukiShibayama | Janssen |
RieKageyama | Sumitomo Pharma |
YasuhikoOzawa | AstraZeneca |
HisaeYagishita | A2 Healthcare |
RyoWatanabe | A2 Healthcare |
TakafumiKamon | A2 Healthcare |
KayoInushima | Biogen |
KeitaTakahashi | Chugai |
ZhengyanLuo | Bristol Myers Squibb |
Published Deliverables | Date |
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09-June-2022 | |
03-May-2023 |