09:00 – 12:00 Workshop A: Understanding Regulatory Requirements for Conducting Early Development Trials in China to Reduce Registration Timelines

(inclusive of morning break)

Regulatory approval in China for early phase clinical trials is always one the most critical challenges. In this workshop, Zaiqi will examine the regulatory requirements, approval process and effective regulatory strategies for early phase clinical trials registration in China. Most importantly, it will focus on how lessons learnt can be applied by sponsors.

This workshop will address:

• Current and proposed legislation for conduction Phase I clinical trials
• Analysis of biological samples: local vs overseas option
• Analysing a practical case of PK trial in China: Risk and opportunities
• Use of foreign data in the early development of New Chemical Entities
• The role of CROs in the early development trials
• Analysing key points that are affecting the approval decisions of early phase trials in China

Facilitator:

Charlie Xu
Vice President, Clinical Services
Frontage Lab China

Dr. Chun(Charlie)Xu has over 28 years of medical practice, academic research, and industry experience in China, Canada, and the U.S. Dr. Xu has a wealth of experience in major aspects of clinical development including medical affairs, operation, and regulatory filing/compliance in US and Canada. He has now moved back to China in 2008 taking the leadership role in clinical operations in one of the major CROs in China before joining Frontage, and now serves as VP Clinical Services in Frontage Lab China.