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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, PhD

Hongbo Zhu, PhD

  • Pfizer, Inc., China

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


Zhimin  Yang, MD

Zhimin Yang, MD

  • Division Director, Center for Drug Evaluation
  • National Medical Products Administration (NMPA), China
Sybille  Eibert

The RegulatoryMedical Writer’s Role in CTD Preparation

Sybille Eibert

  • Manager Medical Writing
  • Actelion Pharmaceuticals Ltd, Switzerland
Helle  Gawrylewski, MA

Helle Gawrylewski, MA

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

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