Dr. Xin Du, CEO of Eglen Pharma, to Chair Panels on FDA Regulatory Updates and Emerging Therapeutics at Upcoming Forum
Evergreen Therapeutics
Innovative Drug Developer
We are honored to have invited to this conference【Evergreen Therapeutics, General Manager Du Xin】AsCo-Planner,AttendNew Trends in FDA Regulatory OversightForum, hosting the roundtable forum for us: [New Trends in FDA Regulatory Oversight] & [New Developments in FDA Regulation of Emerging Medical Products】
Dr. Du Xin has extensive experience in biopharmaceuticals and small molecule products. He served as a CMC review expert at the U.S. FDA and later worked for pharmaceutical companies such as Aventis, Wyeth, Novartis, BMS, NPS, and Arno Pharmaceuticals. Having gone through multiple mergers and acquisitions, he possesses unique expertise in drug registration and regulation and is familiar with the relevant regulations concerning drug development, manufacturing, quality management, clinical design, and trials.
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◈ 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
Senior Vice President and Global CBO of Stem Pharmaceuticals
◈ 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 Developments 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 Pharmaceutical Group
◈ 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 Jin
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 Evaluation 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 Chief Scientific Officer, Libang Pharmaceuticals
*The list of guests and agenda are continuously updated. Please refer to the onsite information....
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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