Drug Evaluation Committee Workshop for Practitioners on Electronic Data Submission at the Time of Application [Day 2 About CDISC standard compliant data
October 08, 2019
- 0_Program (145KB)
- 1_Challenges to electronic data submission at the time of application from almost zero CDISC standard experience (1.1MB)
- 2_What is Legacy data conversion? Collaboration with a global team starting from "What is Legacy data conversion?
- 3_Efficient Collaboration with Global Teams in Electronic Data Submission (444KB)
- 4_Submission experience reveals future challenges for simultaneous submission in Japan, the U.S., and Europe (1.6MB)
- 5_Considerations for effective and efficient quality management activities in outsourced electronic data submission (386KB)
- 6_Consultation with authorities at CROs - Introduction of support cases regarding Gateway response (1.2MB)
- 7_Current status of CDISC standard compliant data submission and points to keep in mind toward the end of the transitional measures period, etc. (974KB)
- 8_Issues and Considerations for Mandatory Electronic Data Submission at the Time of Application (1.3MB)
- 9_Experiences and future challenges of electronic data submission and obtaining approval at the time of application - from the viewpoint of developmental drug affairs and biostatistics - (629KB)
- 10_Question and Answer session (67KB)