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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
Covington & Burling LLP, China
Managing Director, China Food and Drug Practice; Partner
Status and Requirements of Regulatory Registration for IND/NDA in China
Daniel Liu, PhD, MSc
Beijing Clinical Service Center, China
President & CSO
How to Design Global Regulatory Drug Development Strategies in China
Patrick Brady, PharmD
IQVIA, United States
Global Head, Therapeutic Innovation & Regulatory Science
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