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Major Reforms and Strengthened International Cooperation – What Is Happening in China?

Track:
Hot Topic/Stand Alone

Day & Time:
April 17, 2:00PM - 3:30PM (Central Europe Standard Time)

Session Number:
S1000

Room Number:
Kairo 1-2

Type:
Session

Title:
Major Reforms and Strengthened International Cooperation – What Is Happening in China?

Chair(s):
Carol Zhu, MBA
Senior Vice President and Managing Director
DIA China, China

Description:
The Chinese legal framework for medical products has undergone major reforms in the last years. The new pieces of legislation are now coming into force one by one. It is most relevant for companies to be abreast with the changes the new legislation brings for this important market. In addition, the China Food and Drug Administration has strengthened and enhanced its international cooperation. The underlying strategy as well as some recent developments will be outlined, such as the role and involvement of CFDA in ICH and ICMRA.

Presentation(s) & Speaker(s):
China Regulatory Reform in Review and Approval and Global Collaboration
Xiaoling Qin
Deputy Director General, Department of International Cooperation
China Food and Drug Adminsitration (CFDA), China

China Regulatory Reform in Review and Approval and Global Collaboration
Xiangyu Wang
Division Director, Department of International Cooperation, China

New Approaches from China Regulatory Authority to Foster Innovation - Industry Perspective
Wendy Yan, MD, MBA
Senior Vice President, Head of Regulatory Affairs
BeiGene (Beijing) Co., Ltd., China

Panel Discussion
Melly Lin
Senior Regulatory Manager, CMC Policy,
Roche(China) Holding Ltd, China

Panel Discussion
Jessica Liu
Tigermed, China