国际创新药监管论坛

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9:00 - 12:00
  • 国际创新药监管论坛
  • International Regulatory for New Drugs Forum
    • 主持人
  • 何如意 , 荣昌生物首席医学官、国投创新首席科学家、原CDE首席科学家
  • HE Ruyi , CMO of RemeGen, CMO of SDIC, Former Chief Scientist of CDE
9:00 - 9:25
  • 主旨报告1
  • Keynote Speech 1
  • 基于QTsome的核酸药物研发和临床转化
  • QTsome-based Nucleic Acid Drug Development and Clinical Translation
  • 赵孝斌 海昶生物创始人兼总裁
  • ZHAO Xiaobin , Founder & Chairman, Zhejiang Haichang Biotech
9:25 - 9:50
  • 主旨报告2
  • Keynote Speech 2
  • 药物伴随诊断的出海机会和挑战
  • Marketing Companion Diagnostics Overseas - Opportunities and Challenges
  • 胡云富 泛生子首席医疗官
  • HU Yunfu , CMO of Genetron Health
9:50 - 10:15
  • 主旨报告3
  • Keynote Speech 3
  • 中国创新药出海同步临床的策略及考量
  • Strategies and Considerations to Conduct Simultaneous MRCT in U.S. and China for Chinese Innovative Drugs
  • 操先华 锐得麦医药联合创始人及董事长
  • Walt CAO , Co-Founder & President of D2V Clinical
10:15 - 10:40
  • 主旨报告4
  • Keynote Speech 4
  • 创新药出海的主要因素分析和路径选择
  • Discussion of Major Factors and Pathways for Domestic Biotech Going to Overseas
  • 肖申 思路迪医药首席医学官
  • XIAO Shen , Chief Medical Officer of 3D Medicines
10:40 - 11:05
  • 主旨报告5
  • Keynote Speech 5
  • 利培酮缓释微球注射剂Rykindo美国获批案例分享
  • Case Sharing of Innovative Drug Rykindo® Approved in the U.S.
  • 孙志刚 绿叶制药集团高级副总裁
  • SUN Zhigang , Group Senior Vice President, Luye Pharma Group Co., Ltd.
11:05 - 12:00
  • 讨论
  • Panel
  • 国际药物监管策略助力中国药企出海
  • International Drug Regulatory Strategies Help Chinese Pharmaceutical Companies to Go Overseas
    • 主持人
  • 陈少羽, 安诺波特律师事务所管理合伙人
  • CHEN Shaoyu, Managing Partner of Arnold & Porter LLP Shanghai Office
    • Panel嘉宾
  • 杜涛，深圳埃格林医药董事长
  • DU Tao，Chairman of Shenzhen Evergreen Therapeutics
  • 李宁，上海君实生物首席执行官
  • LI Ning，CEO of Shanghai Junshi Biosciences
  • 胡云富，泛生子首席医疗官
  • HU Yunfu，CMO of Genetron Health
  • 肖申，思路迪医药首席医学官
  • XIAO Shen，Chief Medical Officer of 3D Medicines
  • 胡育志，FDA律师，前FDA资深政策顾问
  • HU Yuzhi, Former Senior Consultant of FDA