Drug Evaluation Committee Workshop for Practitioners on Electronic Data Submission at the Time of Application
Feb 15, 2021
- 00_Program (397KB)
- 01_Collaboration of Global team, Global CRO and Japan team -Be on the same page- (3.3MB)
- 02_Industry Response to the New Validation Rules and Challenges (701KB)
- 03_Introduction of the results of the questionnaire regarding the consultation on the exemption of electronic data submission (865KB)
- 04_Results of the case study on the explanation of validation errors in electronic application data and case studies (1.7MB)
- 05_UseCase report on integrated analysis and legacy data conversion (521KB)
- 06_Introduction to the collection of resources related to electronic application data (2.8MB)
- 07_Current status of submission of CDISC standard compliant data and points to note (1.0MB)
- 08_ Points to keep in mind when submitting electronic data for clinical pharmacology - Update based on experience of consultation and data receipt - (2.7MB)
- 09_ How much of Gateway can be outsourced? (At the time of application for approval) (1.5MB)
- 10_ Application electronic data submission - from a project management standpoint (623KB)
- 11_ Toward submitting to multiple regulatory authorities - in light of the start of electronic data submission in China (1.7MB)