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Spotlight on China Regulatory Reform and Acceleration in Simultaneous New Drug Development
Session Chair(s)
Fengyun (Vicky) Han
Senior Director, Head of Regulatory Policy for Asia Pacific
Johnson & Johnson Pte. Ltd., Singapore
This session will provide an overview on regulatory reform outcomes, showcase various expedited pathways for acceleration simultaneous drug development and introduce the China Intellectual Administration Action Plan (IAAP) and how it advances drug supervision by digital technology.
Learning Objective : Describe overall regulatory reform outcomes and give an introduction of various accelerations schemes supported by real time data; Discuss a blueprint of China Intellectual Administration Action Plan (IAAP) and its outcomes on digital technology advance drug supervision and big data. 3. Simultaneous Drug Development Strategy case study sharing in accelerating approvals in China & EU/US
Speaker(s)
The bluprint of China Intellectual Administration Action Plan (IAAP) and how it advances drug supervision by digital technology
Yang Liu
NMPA, China
Senior Engineer,Information Center
Overall regulatory reform outcomes and introduction of various accelerations schemes supported by real time data
Jun Zhao
NMPA, China
Office of Statistics and Clinical Pharmacology, Center for Drug Evaluation
Simultaneous Drug Development Strategy Case Study Sharing in Accelerating Approvals in China and EU/US
Xiaojun (Wendy) Yan, MD, MBA
BeiGene (Beijing) Co., Ltd., China
Senior Vice President, Chief Regulatory Officer
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