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Electronic Data Submission in Japan
| 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 | |
| Nicola Newton, PHUSE Project Coordinator |
| Published Deliverables | Date |
|---|---|
| 09-June-2022 | |
| 03-May-2023 |
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