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M8: Regulatory Operations Management in CTD/eCTD Submission
Session Chair(s)
Daniel Liu, PHD, MSC
President & CSO
Beijing Clinical Service Center, China
As a member of ICH Management Committee, NMPA is actively advancing the implementation of CTD/eCTD in the new drug application and approval. Inaddition to the five CTD modules written format standard requirements and data file format, how to converse paper CTD to eCTD, access the electronicsubmission of data and data files, create life cycle file specification management and file archiving, etc, are the new tasks and challenges faced by the drug regulatory affairs professionals. From CTD to eCTD is not only an electronic process, it contains many systematic standards, such as document managementstandards, medical coding standards, file granularity standards, data transmission standards, system structure standards and so on. This workshop willdiscuss the operation technical requirements of eCTD submission, the file conversion management of data and its data files, as well as the submission formatrequirements of eCTD.