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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
National Medical Products Administration (NMPA), China
Deputy Director, Center for Drug Evaluation
The RegulatoryMedical Writer’s Role in CTD Preparation
Sybille Eibert
Johnson & Johnson, Switzerland
Associate Director Medical Writing
Helle Gawrylewski, MA
Hawkwood Consulting, LLC, United States
Owner