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Session 0905 Regulatory Writing: CTD, ICH E3 - Compliant CSR, and China Submission Dossier Preparation
Session Chair(s)
Hongbo Zhu, PhD
Pfizer, Inc., China
Speaker(s)
Zhimin Yang, MD
Zhimin Yang, MD
National Medical Products Administration (NMPA), China
Director of the Oncology Division, CDE
The RegulatoryMedical Writer’s Role in CTD Preparation
Sybille Eibert
Actelion Pharmaceuticals Ltd, Switzerland
Associate Director Medical Writing
Helle Gawrylewski, MA
Helle Gawrylewski, MA
Hawkwood Consulting, LLC, United States
Owner
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