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Global Drug Development in China: Opportunities and Challenges for Innovation
Session Chair(s)
Joseph Scheeren, PharmD
Founder, Scheeren HealthCare LLC, United States
China has very dynamic regulatory policies in driving the development of innovative drugs. This forum will share experiences on regulatory opportunities and barriers that will impact development and availability of new drugs in China.
Learning Objective : Recognize the regulatory landscape in China; Discuss global drug development strategies in China including the utilization of multiregional clinical trials; Evaluate issues associated with drug lag for the approval of new medicines.
Speaker(s)
Understanding Regulatory Laws and Policies
Shaoyu Chen, JD
Managing Director, China Food and Drug Practice; Partner, Covington & Burling LLP, China
Status and Requirements of Regulatory Registration for IND/NDA in China
Daniel Liu, PhD, MSc
President & CSO, Beijing Clinical Service Center, China
How to Design Global Regulatory Drug Development Strategies in China
Patrick Brady, PharmD
Global Head, Therapeutic Innovation & Regulatory Science, IQVIA, United States
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