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The 7th DIA China Annual Meeting


Session 0406 Quality and Integrity of Clinical Trial Data

Session Chair(s)

Daniel  Liu, PhD, MSc

Daniel Liu, PhD, MSc

  • Chairman, Chief Scientific Officer/Co-founder
  • Beijing Clinical Service Center, China

An Emerging Regulatory Landscape Impacting Quality and Integrity of Clinical Data Submission Trial Master File

Speaker(s)

Qin  Huang, PhD

Qin Huang, PhD

  • Deputy Director, Office of Biostatistics
  • Center For Drug Evaluation, CFDA, China
Daniel  Liu, PhD, MSc

An Emerging Regulatory Landscape Impacting Quality and Integrity of Clinical Data Submission Trial Master File

Daniel Liu, PhD, MSc

  • Chairman, Chief Scientific Officer/Co-founder
  • Beijing Clinical Service Center, China
Jingwei  Gao

Summary level clinical site data for data integrity review and inspection planning in NDA and BLA submission

Jingwei Gao

  • Regional Head,Regional Statistical Programming – Pan Asia META
  • Boehringer Ingelheim (China) Investment Co., Ltd., China

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