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Data and Data Standard Management under ICH-GCP Guideline
Session Chair(s)
Daniel Liu, PhD, MSc
President & CSO
Beijing Clinical Service Center, China
After NMPA became a member of ICH management committee, the R&D of innovative drugs has been developed rapidly, and many first-in-class products areready to do overseas application. This requires better clinical data quality and data standard management. This workshop will focus on the discussion for regulatory requirements of clinical data standard, the establishment of QMS, risk management and datadocument that comply with ICH-GCP guideline to advance clinical application readiness and transformation and implementation of data standard.
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