Innovative Drug Developer

We are honored to have invited to this conference【Evergreen Therapeutics, Co-Founder & CMOLi Changqing】AttendNew Developments in FDA Regulatory OversightForum, bringing us the theme sharing 【Trends and Responses in FDA AI Review】
Dr. Li Changqing holds a Master's degree in Hospital Management from the University of Alabama at Birmingham and a Doctorate in Public Health. He is a licensed physician in the United States and has obtained certification as a specialist in clinical pathology. He once served as a senior medical reviewer at the U.S. FDA and was the first Chinese international student to enter the FDA’s clinical review process as a physician. Dr. Li has extensive global clinical trial experience ranging from Phase I to Phase IV studies in areas such as oncology, immunotherapy, anti-inflammatory treatments, gastrointestinal diseases, and gynecological conditions. He has led hundreds of clinical trials worldwide and over 30 new drug applications.
◈ 09:00-09:25
Regulation Under the New FDA Policy
WangYaning
Evergreen Therapeutics, Founder & CEO
◈ 09:25-09:50
Trends and Responses in FDA AI Review
Li Changqing
Evergreen Therapeutics, Co-Founder & CMO
◈ 09:50-10:15
Considerations for Submitting Chinese Clinical Data to the US
Yuwen Gao
StemMed Senior Vice President and Global CBO
◈ 10:15-10:40
FDA Non-Clinical AI Review and Organoid Applications
Han Xiaomei
BroadLeap Bio, Founder & CEO
◈ 10:40-11:05
FDA New Non-Clinical Regulations and Response Strategies
Zhang Yongbin
JOINN Laboratories, Vice President and Chief Technology Officer
◈ 11:05-12:00
Panel: New Trends in FDA Regulatory Oversight
[ Host ]
Du Xin Evergreen Therapeutics, CEO
[ Guest ]
Li Changqing Evergreen Therapeutics, Co-Founder & CMO
Yuwen Gao Senior Vice President and Global CBO of Stem Pharmaceuticals
Han Xiaomei BroadLeap Bio, Founder & CEO
Zhang Yongbin Vice President and Chief Technology Officer of JOINN Laboratories
◈ 12:00-13:30
Lunch
◈ 13:30-13:55
New Trends in cGMP Compliance Regulation
Sun Zhigang
Senior Vice President of GreenLeaf Pharmaceuticals
◈ 13:55-14:20
New Developments in FDA Regulation of Botanical Drugs
Dou Jinhui
Former Senior FDA Review Expert
◈ 14:20-14:45
Communication on Interdisciplinary Key Controversial Issues in EOP2 Meetings
Yang Jing
Professor at the Center for Drug Metabolism Research, China Pharmaceutical University
◈ 14:45-15:10
Non-Clinical Safety Evaluation Studies of Advanced Therapy Products and the Application of New Safety Assessment Methods
Lu Jinhua
Stardust Bio, Co-Founder, CSO
◈ 15:10-15:35
Application of Real-World Data in New Drug Clinical Development
Shen Xiao
Libang Pharmaceuticals, Chief Scientific Officer
◈ 15:35-16:20
Panel: New Developments in FDA Regulation of Emerging Medical Products
[ Host ]
Du Xin Evergreen Therapeutics, CEO
[ Guest ]
Sun Zhigang Luye Pharma Group, Senior Vice President
Dou Jinhui Former Senior FDA Review Expert
Yang Jing Professor at the Center for Drug Metabolism Research, China Pharmaceutical University
Lu Jinhua Stardust Bio, Co-Founder, CSO
Sherry Xiao Libang Pharmaceuticals, Chief Scientific Officer
*Guests and agenda are continuously updated, subject to the actual event on site....
For business cooperation such as exhibition participation, sponsorship, and co-organization, please feel free to inquire:
CMC Pharma Expo 400-1662-808
Ms. Li 18215607723 (Same for WeChat)
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