中国CRO迈向国际市场之路研讨会·北京·2008年3月19日

国CRO迈向国际市场之路研讨会
ROAD TO GLOBAL MARKET FOR CHINA CLINICAL RESEARCH
——如何携手中心实验室参与国际CRO竞争
ROLE OF CENTRAL LABORATORY

在中国生物医药产业跨入二十一世纪之时，伴随着全球化浪潮和药物研发外包向亚洲转移的趋势，CRO及中心实验室作为新的产业正在中国崛起。国际一流CRO公司均可以为客户提供包括中心实验室在内的一站式服务，中国CRO公司欲参加国际竞争就要尽快在质量及服务体系方面与国际接轨，并熟悉其游戏规则。此次研讨会旨在了解国际CRO的运行模式，与其高层直接对话。为此，我们成功邀请到全球领先的CRO——美国 PPD公司（Nasdaq：PPDI, 市值50多亿美元）高级副总裁Fede博士和亚洲区总裁K. C. Lau先生来本研讨会共同对话。

As China becomes more important in global pharmaceutical R & D outsourcing industry, CRO and central laboratory start taking their roles as well. The challenge is how to meet the international standards and be competitive in the global market. The forum will be discussing the international rules and how China will play in the global market. Peking Union Lawke has invited senior leaders of PPD（Nasdaq: PPDI）to speak in the forum.

一、时 间Time
2008年3月19日下午2:00-5:30
March 19, 2008 2:00-5:30pm
二、地 点Location
北京中关村生命科学园创新大厦2层报告厅
Auditorium, F2, Innovative Building, Zhongguancun Life Sciences Park, Beijing
三、主 办 Organizer
中国医学科学院、北京协和医学院检验医学研发中心
Center for Clinical Laboratory Development (CCLD) of CAMS&PUMC.
北京协和洛奇生物医药科技发展有限公司
Peking Union Lawke Biomedical Development Limited
美国PPD全球中心实验室
PPD Global Central Laboratories
中关村生命科学园
Zhongguancun Life Sciences Park

请于3月15日前将回执传真或e-mail至：中国医学科学院、北京协和医学院检验医学研发中心
Please return registration form via fax or email before March 15, 2008 to Center for Clinical Laboratory Development (CCLD) of CAMS&PUMC.

联系人 Contact: 闫 峻 Bill Yan
电 话 Tel: 86-10-80720625转1121 86-10-80720625 ext 1121
手 机 Mobile: 86-13910583163
传 真 Fax: 86-10-80720652
邮 箱 Email: clab@lawke.com

日程安排（2008年3月19日下午）
Agenda (March 19, 2008)
1:30-2:00 pm 来宾签到
Registration
2:00-2:10 pm 中关村生命科学园董事长致辞，介绍来宾
Welcome and Introduction
2:10-3:00 pm 全球药物研发:中国的角色及其对中心实验室数据和服务需求的影响
Global Drug Development – Emerging Role of China and its Impact on Central Laboratory Data and Service Requirements
摘要 Abstract: Driven by globalization trends, China plays an increasingly important role in clinical trials. With the rapid growth of Chinese investigative sites and trial subjects, laboratory work must be performed intra muros for logistics and regulatory considerations. This sets entirely new requirements on Chinese labs performing clinical trial work as the lab results affect the value of the global clinical database, its statistical analysis and the regulatory submission thereof. We will review the industry trends, laboratory requirements and data impact driving the selection of central laboratories involved in global drug development
演讲人Speaker：Agostino L. Fede, Ph.D.
3:00-3:50 pm 中国中心实验室的质量体系建设及对临床试验的支持
China Central Laboratory: Quality Setup and Support to Clinical Trials.
摘要 Abstract: China is facing a great challenge in meeting the global laboratory standards in terms of quality, processes and overall management. As more global clinical research is coming to China, central laboratory becomes either fuel or bottle neck in winning trials. We will review current laboratory regulatory requirements and overall laboratory set up in China. How to set up a high quality clinical central lab will be discussed based on our directorship experiences in both China and US.

演讲人 Speaker: 何健 博士 James Jian Ho, M.D., Ph.D., DABCC
3:50-4:00 pm 茶歇
Coffee Break
4:00-4:50 pm 中国的临床试验管理：挑战与机遇
Clinical Trial Management in China: Challenges and Opportunities.
摘要 Abstract: China has become more and more important in the global development programs of big pharmaceutical companies because of the shortening of the global product development timelines, and the market potential within China. The author has seen a big improvement in the clinical research environment in China in the last 15 years. Challenges and opportunities of conducting clinical research in China will be reviewed.
演讲人 Speaker: K. C. Lau, Ph.D.
4:50-5:30 pm 参观协和洛奇中心实验室
Laboratory Tour

这不明摆着给PPD做广告吗