Original Innovations from Unmet Clinical Needs Promote China Pharmaceutical Globalization Forum


8:30 AM-12:00 AM 第一阶段 Phase I Moderator
  • 何如意, 中国医药创新促进会国际创新药物监管专业委员会主任委员、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, Chairman of PhIRDA International Regulatory Science Specialty Committee, CMO of RemeGen, CMO of SDIC, Former Chief Scientist of CDE
8:30 AM-8:55 AM 第一阶段 Phase I
  • 主旨报告 1
  • Keynote Speech 1
  • 对创新药物未满足的临床需求的一点思考
  • Opportunities and Challenges of Innovative Drugs – Unmet Clinical Demands
  • 温弘,上海生物医药基金合伙人
  • WEN Hong,Partner of Shanghai BioPharma Fund
8:55 AM-9:20 AM
  • 主旨报告 2
  • Keynote Speech 2
  • 药物递送系统作为源头创新在未满足临床需求中的个案分析
  • Case Studies on Innovative Drug Delivery System towards Unmet Clinical Needs
  • 魏晓雄,汉都医药创始人、首席医学官
  • Jim WEI, Founder and CMO of Shanghai WD Pharmaceutical Co., Ltd
9:20 AM-9:45 AM
  • 主旨报告 3
  • Keynote Speech 3
  • 创新医疗器械临床评价的科学设计及监管
  • Scientific Design and Regulation of Novel Medical Devices
  • 胡云富,泛生子首席医学官
  • HU Yunfu, CMO of Genetron Health
9:45 AM-10:10 AM
  • 主旨报告 4
  • Keynote Speech 4
  • mRNA疫苗的临床设计及监管考量
  • Clinical Study Design and Regulatory Considerations of mRNA Vaccines
  • 门宇欣,浙江海昶生物医药首席医学官
  • Angela MEN, CMO of Zhejiang Haichang Biotech
10:10 AM-10:35 AM
  • 主旨报告 5
  • Keynote Speech 5
  • 创新药临床试验期间药物安全警戒及中美差异
  • Pharmacovigilance During New Drug Clinical Trials and the U.S.-China Gap
  • 丁洪流,北京卡替医疗副总裁
  • DING Hongliu, Vice President of Chineo
10:35 AM-11:00 AM
  • 主旨报告 6
  • Keynote Speech 6
  • 从Aducanumab治疗AD的新药获批,看FDA新药审批标准的改变
  • New Trends in FDA New Drug Approvals - Case Study of Aducanumab for AD Therapy
  • 何如意,中国医药创新促进会国际创新药物监管专业委员会主任委员、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, Chairman of PhIRDA International Regulatory Science Specialty Committee, CMO of RemeGen, CMO of SDIC, Former Chief Scientist of CDE
11:00 AM-12:00 AM
  • 主题讨论
  • Panel
  • 从临床开发角度讨论医药源头创新
  • Original Innovations from Clinical Study Design
  • Moderator
  • 陈少羽,美国安诺波特律师事务所驻上海代表处管理合伙人
  • CHEN Shaoyu,Managing Partner of Arnold & Porter LLP Shanghai Office Panelists
  • 温弘, 上海生物医药基金合伙人
  • 魏晓雄,汉都医药创始人、首席医学官
  • 胡云富,泛生子首席医学官
  • 丁洪流, 北京卡替医疗副总裁
  • WEN Hong, Partner of Shanghai BioPharma Fund
  • Jim WEI, Founder and CMO of Shanghai WD Pharmaceutical Co., Ltd
  • HU Yunfu, CMO of Genetron Health
  • DING Hongliu, Vice President of Chineo
Specification:
  • Released: September 17, 2020
  • Last update: September 19, 2020
  • Version: 1.1