Session I:Innovation Translation:Policy Guidance and Scientific Pactice
主持人 Moderator
崔一民, 中国医药创新促进会创新转化与临床开发专委会资深主任委员,北京大学临床药理研究所所长
CUI Yimin, Eminent Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Director of Institute of Clinical Pharmacology, Peking University
14:00 - 14:25
主题报告1
Keynote Speech 1
ICH E6R3 及国际监管新规对中国创新药早期临床试验的影响与应对
Impact and Response of ICH E6R3 and New International Regulatory Rules on Early Clinical Trials of Innovative Drugs in China
李海燕, 中国医药创新促进会创新转化与临床开发专委会主任委员,北京大学第三医院药物临床试验中心主任
LI Haiyan, Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Director of Drug Clinical Trial Centre,Peking University Third Hospital
14:25 - 14:50
主题报告2
Keynote Speech 2
监管科学视角下的研究者发起临床研究与前沿治疗创新(以细胞基因治疗为例)
Investigator-Initiated Clinical Research and Cutting-Edge Therapeutic Innovation from a Regulatory Science Perspective (Taking Cell Gene Therapy as an Example)
高晨燕, 中国医药创新促进会创新转化与临床开发专委会副主任委员,昌平国家实验室首席科学家
GAO Chenyan, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Leading Scientist at Changping Laboratory
14:50 - 15:15
主题报告3
Keynote Speech 3
罕见病创新药的医疗和社会价值
The Medical and Social Value of Innovative Drugs for Rare Diseases
韩晓红, 中国医药创新促进会创新转化与临床开发专委会副主任委员,北京协和医院临床药理研究中心主任
HAN Xiaohong, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Professor, Director, Clinical Pharmacology Research Center,Peking Union Medical College Hospital
15:15 - 17:00
第二阶段:临床开发:前沿突破与协同创新
Session II:Clinical R&D:Frontier Breakthroughs and Collaborative Innovation
主持人 Moderator
朱畴文, 中国医药创新促进会创新转化与临床开发专委会副主任委员,上海临床研究中心主任
ZHU Chouwen, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
President, Shanghai Clinical Research and Trial Center
15:15 - 15:40
主题报告4
Keynote Speech 4
新政下创新药I期试验和仿制药BE试验的临床实施
Clinical Implementation of Phase I Trials for Innovative Drugs and BE Trials for Generic drugs under the New Policy
ZHANG Jing, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Chief Physician, Associate Professor and Doctoral Supervisor in the Department of Pulmonary Medicine of Shanghai Zhongshan Hospital, Fudan University
15:40 - 16:05
主题报告5
Keynote Speech 5
研究型医院如何助力创新性临床研究
How Research Hospitals Support Innovative Clinical Research
郑晓宇, 高博医疗集团CEO
ZHENG Xiaoyu, CEO of GoBroad Healthcare Group
16:05 - 17:00
主题讨论
Panel
先进技术赋能早期转化临床——机遇、挑战与监管协同
Advanced Technologies Empower Early Translational Clinical Practice: Opportunities, Challenges, and Regulatory Collaboration
主持人 Moderator
郭彤, 中国医药创新促进会创新转化与临床开发专委会副主任委员,高博医疗集团战略顾问
GUO Tong, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee,
Gobroad HealthCare Group Strategic Advisor
WANG Xinghe, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Director of Beijing Municipal Center for Clinical Research Quality Promotion,Honorary Director of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University
方翼, 北京大学人民医院临床试验机构I期临床试验研究室主任
FANG Yi, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Director of Phase I Clinical Trial Laboratory,, Peking University People's Hospital
李长青, 埃格林医药联合创始人、首席医学官
Charles Lee, Co-founder,Chief Medical Officer of Evergreen Therapeutics
田正隆, 上海医药中央研究院常务副院长
TIAN Zhenglong, Vice-Chairman of PhIRDA Innovation Translation and Clinical Development Specialty Committee
Executive Deputy Dean, Central Research Institute, Shanghai Pharma Group