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2018-11-06
2018-11-28
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Speaker: Heidi Wang, Vice President and Head of Global Regulatory Science- China and Hong Kong, Bristol-Myers Squibb Company (BMS)

Time: Nov 28, 2018 (Wednesday), 9 - 10 PM, EST
Title sponsor: Luye Pharma Group, Ltd.

China has implemented a series of regulatory changes and improvements through a comprehensive regulatory reform starting in August 2015. This webinar will provide a high level introduction of the China health authority (HA) organization as well as the Investigational New Drug (IND) / Clinical Trial Application (CTA) and the New Drug Application (NDA) process. The efforts China HA took to shorten the review time and reduce the current druglag for approvals in China (time gap between approval in China and approvals from US Food and Drug Administration (FDA) and European Medicines Agency (EMA) will be shared.
Dr. Heidi Wang is the Vice President and Head of Global Regulatory Science-China and Hong Kong, Bristol-Myers Squibb Company (BMS). She has led the teams to obtain the first HCV direct acting agents (Daklinza and Sunvepra) and the first Immuno-Oncology PD(L)-1 inhibitor (Opdivo) approvals in China. Prior to China, Dr. Wang had 22 years of experience working in BMS US headquarter.

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