The Design and Regulation of Clinical Trials: Case Studies in China and the U.S.

All day

Mar.
26

The Design and Regulation of Clinical Trials:
Case Studies in China and the U.S.

临床试验的设计和监管:中国和美国的案例分析

 

Sponsors

  • Peking Union Medical College Hospital
  • Clinical Pharmacology Research Center
  • The University of Chicago
  • Graham School of Continuing Liberal and Professional Studies
  • The University of Chicago Center in Beijing

主办方

  • 北京协和医院临床药理研究中心
  • 芝加哥大学格莱姆继续教育学院
  • 芝加哥大学北京中心

Investigators, researchers, site managers and clinical monitors need adequate training in clinical research design and implementation, good clinical practices, data collection and management and related issues.  Additionally, Chinese pharmaceutical manufacturers and research hospitals can benefit from a wider understanding of the USFDA approval process, how clinical research operations function in the United States and what multinational pharmaceutical and biotech companies require from research centers and partners in China.

调查人员、研究人员、现场管理人员和临床监测员需要在临床研究设计和实施、良好的临床实践、数据收集和管理及其他相关问题方面获得适当的培训。此外,中国制药企业和研究型医院可以从美国FDA的审批流程中获得更广泛的理解,临床研究手术在美国的作用如何、跨国制药和生物技术公司在中国的研究中心和合作伙伴中所需求的是什么等等。

 

March 26th, 2015

9:00 – 9:05am: Video: A Century of Collaboration – Chinese Academy

of Medical Sciences & Peking Union Medical College/Peking Union Medical College Hospital and the University of Chicago

9:05 – 9:15am: WELCOME

Dr. Huanling Wang, Deputy Director, Peking Union Medical College Hospital Clinical Pharmacology Research Center
Mary Daniels, Associate Dean, Bridge and Partnership Programs, University of Chicago Graham School of Continuing Liberal and Professional Studies
Morning Session Chair: Mary Daniels, UChicago

9:15 – 9:45am: KEYNOTE: Clinical Trials in China from the Perspective of PUMCH Experience

Dr. Huanling Wang, Peking Union Medical College Hospital

9:45 – 10:00am: Q&A

10:00 – 10:30am: KEYNOTE: Clinical Research at the University of Chicago Comprehensive Cancer Center from a Regulatory Perspective

Dr. Sumati Murli, Director of Clinical Research Operations,

University of Chicago Comprehensive Cancer Center

10:30 – 10:45am: Q&A

10:45 – 11:00am: BREAK

11:00 – 11:30am: Introduction to U.S. Food and Drug Administration’s China Office and Regulation of Clinical Trials

Nicole Taylor Smith, Assistant Country Director, U.S. Food and Drug Administration, China Office, U.S. Embassy Beijing

11:30 – 11:45am: Q&A

11:45 – 12:15pm: Oversight of Clinical Trials in China

Xue Qian, Deputy Division Director of Drug Inspection Office I, Centre For Food and Drug Inspection, China Food and Drug Administration (CFDA)

12:15 – 12:30pm: Q&A

12:30 – 1:30pm: LUNCH at the University of Chicago Center in Beijing (Note: Vegetarian Bento)

 

Afternoon Session Chair: Dr. Huanling Wang, PUMCH

1:30 – 2:00pm: IEC/IRB Review in PUMCH

Dr. Hua Bai, Assistant Director, Peking Union Medical College Hospital Clinical Pharmacology Research Center

2:00 – 2:15pm: Q&A

2:15 – 2:45pm: Observership and Visiting Scholar Programs in Cardiology at the University of Chicago

Dr. Jafar Al-Sadir, University of Chicago Medical Center, Director, Cardiology Observership and Visiting Scholar Program

2:45 – 3:00pm: Q&A

3:00 – 3:30pm: Challenges and Opportunities for Conducting Large Clinical Trial in China

Dr. Lixin Jiang, Director of International Collaborative Centre, NCCD; Director of the National Bio-Bank Centre for CVD, NCCD;

Executive Deputy Director of National Clinical Research Centre

Dr. Xi Li, Assistant Director of Data Management and Analytics, China Oxford Centre for International Health Research, Fuwai Hospital, National Centre of Cardiovascular Diseases

3:30 – 3:45pm: Q&A

3:45 – 4:00pm: BREAK

4:00 – 4:30pm:  Investigator-initiated Translation/Clinical Trials: From Bench to Bedside

Dr. James Liao, Chief of Cardiology, University of Chicago Medical Center

4:30 – 4:45pm: Q&A

4:45 – 5:00pm: Conference Concludes

 

会议日程

9:00 – 9:05am: “跨越世纪的合作–中国医学科学院、北京协和医学院、北京协和医院与芝加哥大学”百年友谊记录短片

9:05 – 9:15am: 会议开幕

王焕玲,北京协和医院临床药理研究中心副主任
Mary Daniels,芝加哥大学格莱姆继续教育学院副院长

上午会议主持人:Mary Daniels, 芝加哥大学

9:15 – 9:45am: 主旨发言: 从北京协和医院的经验中探讨中国的临床试验

王焕玲,北京协和医院临床药理研究中心副主任

9:45 – 10:00am: 提问与回答

10:00 – 10:30am: 主旨发言: 芝加哥大学综合癌症中心的临床研究:管理的视角

Sumati Murli,芝加哥大学综合癌症中心临床研究办公室主任

10:30 – 10:45am: 提问与回答

10:45 – 11:00am: 茶歇

11:00 – 11:30am: 美国FDA中国办事处及临床试验监管

Nicole Taylor Smith,美国驻华使馆美国FDA中国办事处助理主任

11:30 – 11:45am: 提问与回答

11:45 – 12:15pm: 中国药物临床试验的监管

钱雪,国家食品药品监督管理总局食品药品审核查验中心检查一处

副处长

12:15 – 12:30pm: 提问与回答

12:30 – 1:30pm: 午餐(芝大北京中心)

下午会议主持人:王焕玲,北京协和医院

1:30 – 2:00pm: 北京协和医院临床试验中的IEC/IRB考量

白桦,北京协和医院临床药理研究中心主任助理

2:00 – 2:15pm: 提问与回答

2:15 – 2:45pm: 芝加哥大学医学院的心内科参观及访问学者项目介绍

Jafar Al-Sadir,芝加哥大学医学院心内科教授、心内科参观及访问学者项目主任

2:45 – 3:00pm: 提问与回答

3:00 – 3:30pm: 中国大规模临床试验的机遇与挑战

蒋立新,国家心血管病中心、阜外医院国家心血管疾病临床医学研究中心、中国牛津国际医

学研究中心主任

李希,国家心血管病中心中国牛津国际医学研究中心

主任助理

3:30 – 3:45pm: 提问与回答

3:45 – 4:00pm: 茶歇

4:00 – 4:30pm: 研究者发起的临床试验:从实验室到临床

廖光然,芝加哥大学医学院心脏科主任

4:30 – 4:45pm: 提问与回答

4:45 – 5:00pm: 会议总结

 

(Photos by Yuxuan Li)