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The Mysterious Regulatory Landscape in China: a Medical Writer’s Perspective
Session Chair(s)
Ruggero Galici, PhD
Director, Nonclinical and Clinical Pharmacology Writing
Alexion Pharmaceuticals, AstraZeneca Rare Disease, United States
This session will provide an overview of the dynamic regulatory environment to support the clinical development of pharmaceutical products in China. Preparation of common and unique medical writing documents to support regulatory submissions will be discussed.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Discuss the Chinese regulatory environment for pharmaceuticals
- Recognize common and unique requirements for regulatory submissions to the Chinese National Medical Products Administration (NMPA)
- Identify specific clinical documents for submissions to the NMPA
Speaker(s)
The Mysterious China Regulatory Environment: Considerations in Clinical Development, Regulatory Submissions, and Medical Writing in China
Hongbo Zhu, PhD
Pfizer, Inc., China