Regulatory Affairs Committee Gateway (Application Electronic Data System) Workshop
Thanks to the efforts of all the participants, the "Gateway (Application Electronic Data System) Workshop" on February 28, 2018 was a great success, and the number of participants exceeded our expectation of 272. Thanks to the understanding of the presenters, the presentation materials of the day (for some of the presentations, printed materials that were included in the handouts are being made available to the public instead of being projected on the day of the workshop. Please understand.) We will release the printed materials. We hope that they will be of help to your company in promoting the use of GW in the future.
- 0_Program (239KB)
- 1_What you should prepare before using electronic data systems (4.3MB)
- 2_Experience and achievements of pharmaceutical companies in using GW (1) (501KB)
- 3_Experiences and Achievements of Pharmaceutical Companies in Using GW (2) (1.8MB)
- 4_Points to keep in mind when outsourcing GW-related work to CROs (CDISC Task Force, Japan CRO Association) (767KB)
- 5_PMDA's Requests to Pharmaceutical Companies for GW Utilization (673KB)
- 6_Case studies of GW-related work by CROs (1) (2.5MB)
- 7_Case studies of GW-related work by CROs (2) (1.5MB)