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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 Email 
Kazuki Fukuzawakazuki.fukuzawa@astrazeneca.com
Koichi Yamaguchi

yamaguchi_koichi@lilly.com

Takashi Kitaharatakashi.kitahara@novartis.com
Shinichi Hotta

shinichi.hotta@sumitomo-pharma.co.jp

Yasuhiro Iijima

yasuhiro.iijima@novartis.com

Yoshiko Kitagawa

yo.kitagawa@ono-pharma.com

Project MembersOrganisation TomohikoFunaiEli Lilly YasuhiroIijima


Novartis 
Published DeliverablesDate 

 Best Practices for the Submission of Data in Japan

09-June-2022

(E) Validation Error

03-May-2023






Project MembersOrganisation 
Eri SakaiNovartis 
Hisae YagishitaA2 Healthcare
Iori Sakakibara
Janssen 
Janssen Research & Development 
Kayo InushimaBiogen
Keita TakahashiChugai 
Noriyuki Shibayama
Janssen AstraZenecaHisaeYagishitaA2 Healthcare
Janssen Research & Development 
Rie KageyamaSumitomo Pharma 
YasuhikoOzawa
Ryo WatanabeA2 Healthcare 
Takafumi KamonA2 Healthcare 
KayoInushimaBiogenKeitaTakahashiChugai 
TomohikoFunaiEli Lilly 
Yasuhiko OzawaAstraZeneca
Yasuhiro IijimaNovartis 
Zhengyan LuoBristol Myers Squibb 
Published DeliverablesDate 

 Best Practices for the Submission of Data in Japan

09-June-2022

(E) Validation Error

03-May-2023