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The 7th DIA China Annual Meeting

Session 0905 Regulatory Writing: CTD, ICH E3 - Compliant CSR, and China Submission Dossier Preparation

Session Chair(s)

Hongbo  Zhu

Hongbo Zhu

  • Head Medical Writing
  • Boehringer Ingelheim International Trading (Shanghai) Co., Ltd. , China

Regulatory Writing CTD, ICH E3-compliant CSR, andChina Submission Dossier Preparation


Zhimin  Yang, MD

Zhimin Yang, MD

  • Division Director, Center for Drug Evaluation
  • China Food and Drug Administration (CFDA), China
Sybille M Eibert

The RegulatoryMedical Writer’s Role in CTD Preparation

Sybille M Eibert

  • Senior Manager Medical Writing
  • Teva Pharmaceuticals International Gmbh, Switzerland
Helle  Gawrylewski, MA

Helle Gawrylewski, MA

  • Co-owner
  • Hawkwood Consulting, LLC, United States

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