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Virtual Event

2021年3月15日 (月) 午前 9:00 - 2021年3月19日 (金) 午後 4:30

(Central Europe Standard Time)

4051 Basel, Switzerland

DIA EUROPE 2021

Spotlight on China Regulatory Reform and Acceleration in Simultaneous New Drug Development

Session Chair(s)

Fengyun (Vicky)  Han

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)

Yang  Liu

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

Jun  Zhao

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

Xiaojun (Wendy)  Yan, MD, MBA

Simultaneous Drug Development Strategy Case Study Sharing in Accelerating Approvals in China and EU/US

Xiaojun (Wendy) Yan, MD, MBA

DIA BOD, China

Strategic Advisor

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