2017

November 6-7 | TANGLA Beijing Hotel

GCP现场核查 - 从自查到核查的管理研讨班GCP Inspection Management Workshop - From Self-inspection (Inspection Readiness) to Inspection Management

11月6-7日 | 北京唐拉雅秀酒店

中国2017

DIA中国微信订阅号 DIA中国微博

从证据到洞见– 循证医学的价值定位及医学策略

2017年12月14-15日 | 上海齐鲁万怡酒店

中国

主要日程

第一天：铸就专业 - 循证医学的价值定位

• 循证医学概览• 数据解读辩证• 医学研究偏误• 真实世界数据

第二天：放大的潜力 - 医学策略从证据到洞见行动

• 临床研究概览• 试验设计的考量• QbD – 试验数据质量• 疾病教育• 文献管理• 医学事务战略核心

会议联系人: 宁尔宁 电话: +86. 10 5704 2655 | 邮箱: Erning.Ning@DIAglobal.org

报名联系人: DIA中国 电话: +86 10 5704 2659 | 邮箱: china@diaglobal.org

微信注册扫描二维码

组委会成员

范帆 MBA药物研发医学顾问 戴鲁燕 博士 勃林格殷格翰泛亚太生物统计负责人 迟海东 博士 礼来中国肿瘤学领域高级医学总监礼来跨治疗领域医学平台负责人 刘熠 武田中国医学事务负责人 李智 勃林格殷格翰 医学事务I 部总监 卫芳 MSD高级医学事务总监

DIA Global Center: Washington, DC, USA | Basel, Switzerland | Beijing/Shanghai, China | Horsham, PA, USA | Mumbai, India | Tokyo, Japan

中国北京市海淀区海淀大街3号A座16层1618室 邮编: 100080 | 电话: +86 10 5704 2659 | www.DIAglobal.org中国上海市徐汇区零陵路599号601室 邮编: 200030 | 电话: +86 21 6042 9857 | China@DIAglobal.org

中国

GCP现场核查 - 从自查到核查的管理研讨班

11月6-7日 | 北京唐拉雅秀酒店

根据‘四个最严’的要求，中国食品药品监督管理总局（CFDA）从2015年7月起组织开展了药物临床试验数据核查工作。截止2017年6月，核查中心已经核

查313药品注册申请。在这个过程中，有些核查过程顺畅，有些却经历曲折。

本课程针对申办方/合同研究组织(CRO)的质量相关工作人员（包括稽查员、质

量经理、核查经理等）、药物临床试验机构工作人员以及研究者，以听众需求

为导向，由中国质量保证论坛的多位专家结合多年的国内外QA 领域工作经验，

亲自设计课程、 讲解与带队练习，并邀请海外及药监领域专家现身说法, 旨在帮

助研究团队更好地准备和高效地配合整个现场核查的流程。整个课程设计务求

实用与创新，不仅有理论指导、经验分享、案例讨论，更引领学员全情投入。

培训目标

• 理解CFDA实施药物临床试验数据核查的全流程与总体要求

• 掌握一些适用于准备阶段与核查现场的实用技巧、工具

• 掌握回复核查不合格项目的要点

• 了解其他主要药政机构实施现场核查的流程与要求

特邀演讲嘉宾

王佳楠总局食品药品审核查验中心研究核查处副处长

Deborah DRISCOLL默克研究实验室质量保证副总裁

Priya CHATURVEDI 博士默克研究实验室质量保证执行总监

组委会联席主席

陈华强生公司质量策略亚太总监

周立萍默沙东研发（中国）有限公司亚太区质量保证总监

组委会成员

刘海涛辉瑞（中国）研究开发有限公司质量保证中国策略主管中国质量保证论坛(CQAF) 现任主席

Ellyne SETIAWAN勃林格殷格翰医学质量负责人

Ching Tsu LIN武田临床质量保证高级项目经理

刘清月罗氏全球药品开发中心质量部资深GCP战略负责人

孙晔百时美施贵宝 全球质量保证亚太区 全球合规专家

王玉书强生研发战略运营及医学事务，质量管理部质量合规经理

洪婷GSK临床质量保证 资深顾问

顾晓慧辉瑞（中国）研究开发有限公司 药政检查管理高级经理

蒋燕敏赛诺菲中国及亚太区研发中心质量运营负责人

会议联系人: Erning NING 邮箱: erning.ning@DIAglobal.org | 电话: +86. 10. 5704 2655

报名联系人: DIA China 电话:010-57042659 | 邮箱: China@DIAglobal.org

Co-host: 中国质量保证论坛 (CQAF) 项目组

会议议程

第一天 | 11月6日 • 星期一 第二天 | 11月7日 • 星期二

8:30 – 9:00 现场报到

9:00 – 9:15 欢迎致辞

周立萍

默沙东研发（中国）有限公司亚太区质量保证总监

9: 15 – 10:15 核查概述

王佳楠

总局食品药品审核查验中心研究核查处副处长

10:15 – 10:30 茶歇

10:30 – 12:00 临床试验中的质量管理全周期-从自查到

核查的管理

陈华

强生公司质量策略亚太总监

12:00 – 13:00 午餐

13:00 – 17:00 核查准备 （中间15分钟茶歇）

• 建立团队

• 文件准备

• 相关培训

• 内外沟通

• 后勤准备

CQAF项目组

17:00 第一天内容结束

8:30 – 9:00 第一天内容回顾

周立萍

默沙东研发（中国）有限公司亚太区质量保证总监

9:00 – 11:30 接待核查 (中间15分钟茶歇）

• 核查开场会议

• 协助文件审阅

• 协调文件调阅和人员面谈

• 内部沟通（现场以及远程支持）

• 不合格项目分类

• 核查结束会

CQAF项目组

11:30 – 12:30 午餐

12: 30 – 15:30 不合格项目的回复

CQAF项目组

15: 30 – 15:45 茶歇

15:45 – 17:00 国际药政机构核查概述及整改预防措施

Deborah DRISCOLL默克研究实验室质量保证副总裁

Priya CHATURVEDI 博士

默克研究实验室质量保证执行总监

17:00 会议结束

About DIA

建立联系 l 增进了解 l 推进创新

DIA（Drug Information Association，药物信息

协会）是一个全球性、中立的组织，旨在为业界提

供自由交流和分享知识信息的平台，促进医疗产品

的创新和开发。

DIA是一家国际性、非营利性、多学科的会员制协

会，为医疗产品开发的专业人员提供中立、透明的

论坛，推动药品和技术的合作和交流，改善全球

健康。DIA的全年活动包括大会（年会和创新药会

议）、培训班、研讨班、沙龙、企业内训定制课程

和在线学习课程，涉及领域包括：监管科学、转化

医学、药学、生物技术、医疗技术等。

DIA总部位于美国首都华盛顿哥伦比亚特区，在美

国（宾夕法尼亚州霍舍姆），欧洲、中东和非洲（

瑞士巴塞尔），中国（北京和上海），日本（东

京）和印度（孟买）均设有地区办事处。

更多信息请见www.DIAglobal.org

微信订阅号微博

About DIADIA (founded as the Drug Information Association) provides is a global, neutral forum where stakeholders can openly and freely exchange knowledge information and insights beyond boundaries to advance innovation in health care product development and lifecycle management globally.

DIA is an interna DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, the Middle East and Africa, (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).

For more information, visit www.DIAglobal.org or connect with us on Twitter, LinkedIn, Facebook, and Instagram.

DIA Global Center: Washington, DC, USA | Basel, Switzerland | Beijing/Shanghai, China | Horsham, PA, USA | Mumbai, India | Tokyo, Japan

DIA China OfficesUnit A1618, Tower A, No. 3 HaiDian Avenue, Hai Dian District Beijing 100080, China | Tel. +86 10 5704 2659 | www.DIAglobal.orgUnit 601, 599 Ling Ling Road, Xu Hui District, Shanghai 200030, China | Tel: +86 21 6042 9857 | China@DIAglobal.org

CHINANovember 6-7 | TANGLA Beijing Hotel

GCP Inspection Management Workshop - From Self-inspection (Inspection Readiness) to Inspection Management

The course targets Sponsor/ CRO GCP quality professionals (Auditors, Quality Manager, Inspection Manager, etc.), hospital GCP officers and Investigators who are involved in an inspection directly. Will cover the essential knowledges for the Clinical Trial Quality Life Cycle Management, as well the handful skills and tools to prepare and host CFDA inspection. The course have invited some most senior Auditors from China Quality Assurance Forum (CQAF) to design, lead and facilitate the whole course.

LEARNING OBJECTIVES

• The insight and prospect of CFDA NDA related GCP inspections• The handful skills and tools to prepare and host CFDA inspection• Response and follow-up to inspection findings• Global knowledge and experience with other health authority inspections

INVITED SPEAKERS

Jianan WANGDeputy Division Chief, Research Inspection, CFDI

Deborah DRISCOLLVice President, Quality Assurance, Merck Research Laboratory

Priya CHATURVEDI, PhDExecutive Director, TA Head Vaccines & ID, MRL Quality Assurance, Merck Research Laboratory

PROGRAM CO-CHAIRS

Hannah CHENDirector, AP, Quality Strategy, Johnson & Johnson

Liping ZHOUDirector, Quality Assurance, Asia Pacific, MSD R&D (China) Co.,Ltd.

PROGRAM COMMITTEE MEMBERS

Heidi LIUActing Quality Assurance Lead, Medical Quality Assurance Pfizer (China) Research and Development Co, Ltd.Chair, CQAF

Ellyne SETIAWANHead of Quality Medicine, ROPU-TCM, Boehringer Ingelheim

Ching Tsu LINSenior Program Manager, Clinical Quality Assurance, Takeda

Cathy LIUSenior GCP Strategy Lead & Site Manager, Roche Pharma Development Quality (PDQ) Shanghai

Lisa SUNQC Expert, QA Asia Pacific, BMS

Yushu WANGQC Manager, Quality Management, Strategy and OperationsChina R&D and Medical AffairsJanssen Research & Development

Lois HONGSenior Consultant, QA, GSK

Sherry GUInspection Management Lead, Medical Quality Assurance, Pfizer

Amy JIANGHead China R&D, Asia Pacific R&D Hub, Sanofi

Co-host : CQAF Project Team

Contact: Erning NINGEmail: erning.ning@DIAglobal.orgTel: +86. 10. 5704 2655

DIA China OfficesUnit A1618, Tower A, No. 3 HaiDian Avenue, Hai Dian District Beijing 100080, China | Tel. +86 10 5704 2659 | www.DIAglobal.orgUnit 601, 599 Ling Ling Road, Xu Hui District, Shanghai 200030, China | Tel: +86 21 6042 9857 | China@DIAglobal.org

CHINA

Agenda

Day 1 I Monday, November 6 Day 2 I Tuesday, November 7

8:30 – 9:00 Registration

9:00 – 9:15 Welcome and Objectives & Rules

Liping ZHOUDirector, Quality Assurance, Asia Pacific, MSD R&D (China) Co.,Ltd.

9:15 – 10:15 Insights on CFDA GCP NDA Inspections

Jianan WANGDeputy Division Chief, Research Inspection, CFDI

10:15 – 10:30 Tea Break

10:30 – 12:00 Clinical Trial Quality Life Cycle Management-- from Self-inspection (Inspection Readiness) to Inspection Management

Hannah CHENDirector, AP, Quality Strategy, Johnson & Johnson

12:00 – 13:00 Luncheon

13:00 – 17:00 Inspection Preparation (Tea Break in between)

• Build the team• Pre-inspection dossier• Training• Internal & External communication• Logistics

CQAF Project Team

17:00 End of Day 1

8:30 – 9:00 Review of First Day

Liping ZHOUDirector, Quality Assurance, Asia Pacific, MSD R&D (China) Co.,Ltd.

9:00 – 11:30 Host Inspection (Tea Break in between)

• Opening meeting• Facilitate document review• Handling Request and interviews• Internal communication (on-site and remote) • Observation clarification• Closing meeting

CQAF Project Team

11:30 – 12:30 Luncheon

12:30 – 15:30 Response to Inspection Findings

CQAF Project Team

15:30 – 15:45 Tea Break

15:45 – 17:00 Global Inspection Overview and CAPA Management

Deborah DRISCOLLVice President, Quality Assurance, Merck Research Laboratory

Priya CHATURVEDI, PhDExecutive Director, TA Head Vaccines & ID, MRL Quality Assurance, Merck Research Laboratory

17:00 End of the Training

讲者介绍 / About the Speakers

陈华 / Hannah CHEN强生公司质量策略亚太总监

Director, AP, Quality Strategy, Johnson & Johnson

Hannah于2012年9月份加入强生亚太与中国研发机构的生物学研究质量与合规部门

（BRQC) 担任质量总监. 2016年9月起，她担任生物学研究质量与合规部门中国区负责

人，负责亚太区和中国区研发部门质量管理系统中战 略性地整合质量保证与合规性的

内容。在加入强生公司之前，Hannah曾在葛兰素史克公司工作15年，其中有10年时间

从事审核工作。她曾在亚太地区的很多国家从事药物临床试验管理规范方面的审核工

作，也在美国、欧洲、拉丁美洲和非洲的很多国家工作过。自2009年起，她就与FDA中国办公室和CFDA密切合作，在药物临床试验管理规范等方面提供了大量的咨询并起

草指南性文件。

Hannah is leading a team of auditors in AP region covering: non-regulated, GLP, GCLP, GCP and PV audits; she also provides strategic input to audit program to ensure risks in AP region are communicated and reflected in the audit program.

She joined Johnson & Johnson in September 2012 from GlaxoSmithKline (GSK). She has worked for GSK for more than 15 years, including 10 years in the area of auditing. Hannah conducted a variety of GCP audits in many AP countries, as well as in US, Europe, Latin America and African countries. She also has experience in PV system audits and clinical lab audits. She has been involved in many internal and external training programs, assisted US FDA inspection training workshop in China from April 2010 to Oct. 2012. Hannah has been working closely with China FDA since 2009, provides consultation and involves in the development of guidance documents in GCP area. Hannah has also spent approximately 5 years in Clinical Research. Prior to joining GSK, Hannah worked for almost 8 months as a sales representative in Mead Johnson.

Hannah obtained her Medical Degree from Capital University of Medical Sciences in China and worked as a Pediatrician for years before joined industry in 1996.

Priya CHATURVEDI, PhDExecutive Director, Quality Assurance, Merck Research Laboratory

Priya Chaturvedi is the MRL Quality Assurance-Therapeutic Area (TA) Head for Infectious Diseases and Vaccines. In addition to her TA role, she is aligned with Quality Assurance in Asia Pacific region. She joined Merck in June of 2016. Prior to that, she was at Pfizer, where most recently she was responsible for Compliance and Quality Oversight of medical and clinical affairs. Prior to that, she was the Director of Compliance and Oversight and had responsibility of quality oversight of large portfolio of clinical studies. Prior to joining Pfizer in 2010, Priya spent 12 years at GSK in different clinical, project management and discovery roles.

She received her Doctorate degree from Temple University, School of Medicine, PA.

Deborah DRISCOLLVice President, Quality Assurance, Merck Research Laboratory

Deborah Driscoll has twenty plus years of broad-based experience working in academia and the pharmaceutical industry. She began her career as a research technician at the Boston VA Medical Center and Boston University. She moved to Hoffmann-La Roche holding positions in pharmacology, neuroscience, oncology and HIV research. Deborah worked at Pfizer for several years working in the areas of clinical research, global pharmacovigilance, drug safety surveillance and quality systems development. Deborah joined Merck as the head of Quality Assurance for Merck Research Laboratories in July 2015. Outside the work place, in 2014 Deborah assumed the leadership role for TransCelerate BioPharma Inc. Clinical Quality Management System Team working with 18+ member companies to develop and advance a clinical quality framework. Deborah has a devoted interest in supporting proactive quality and compliance initiatives globally. Deborah holds a B.S. in Animal Science and an M.S. in Biology.

顾晓慧 / Sherry GU辉瑞医学治疗保证部药政检查管理高级经理

Inspection Management Lead, Medical Quality Assurance, Pfizer China

顾晓慧，现任辉瑞医学治疗保证部药政检查管理高级经理。主要负责辉瑞的GCP及PV药政核查(包括申办方核查，研究机构核查及供应商核查等)的相关准备，组织和管理

工作。在获得中医学硕士学位后,任职于精鼎医药从事临床研究监察员工作五年。并于

2012年至2016年担任勃林格殷格翰合规经理，于2017年起任职辉瑞。

Sherry Gu serves as Inspection Management Lead of the Medical Quality Assurance department in Pfizer China. She is responsible for preparing for, organizing and leading Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections in Pfizer (sponsor, investigator site, vendor, as appropriate) conducted by global Health Authorities/Regulatory Authorities (HAs/RAs), and pharmacovigilance audits conducted by license partners, as appropriate.

Sherry Gu was Boehringer Ingelheim’s Compliance Manager from year 2012 to 2016 and previously, she worked for Parexel as Clinical Monitor for 5 years after earned her Master degree of Traditional Chinese Medicine.

讲者介绍 / About the Speakers

讲者介绍 / About the Speakers

蒋燕敏 / Amy JIANG 赛诺菲中国研发中心运营负责人

Head, China R&D, Sanofi

• 临床医生

• 上海胸科医院，肺内科肿瘤医生5年• 赛诺菲，10余年临床运营经验（尤其是肿瘤、糖尿病、心血管等领域）

• 赛诺菲，7年余GxP质量管理及运营经验

• Medical Doctor by training• 5-year Oncologist in Pulmonary Department in Shanghai Chest Hospital• 10-year+ in Clinical Operations, especially in Oncology, Diabetes, Cardiovascular, etc. in

Sanofi• 7-year+ in GxP Quality Operations & Quality Management in Sanofi

Ching-Tsu Lin, M.S.

Ching-Tsu Lin, M.S., has worked extensively with both sponsors and CRO as CRA , project manager, training/ compliance manager over the past 9 years. Throughout her career, she has gained extensive experience with coordinating and investigating quality issues and work with functions in developing CAPA, design training programs, lead/facilitate GCP inspections.

刘清月 / Cathy LIU罗氏全球药品开发质量保证部上海地区负责人, 资深GCP战略负责人

Senior GCP Strategy Lead & Site Manager for Roche Pharma Development Quality (PDQ) Shanghai

刘清月女士现任罗氏全球药品开发质量保证部上海地区负责人和资深GCP战略负责人，

主要职责包括为公司药物研发过程中（早期临床开发，临床研究和药品上市后）的活动

制定稽查战略和制定应对各国药监部门的视察战略，以及通过与公司各部门的合作确保

全球质量保证部的战略顺利地实施并为罗氏全球药品开发中心（上海）和亚太区国家的

分支机构提供质量保证的支持和服务。

刘清月女士具有超过20年的制药行业经验，先后服务于三家国际制药公司从事临床试验

运营，质量与培训和质量保证的管理工作。稽查经验涉及GCP，GCLP，和GVP领域，

稽查的区域主要涉及亚太区各国以及欧洲和美国。

Cathy currently holds the position of Senior GCP Strategy Lead & Site Manager for Roche Pharma Development Quality (PDQ) Shanghai. Have been working in Pharmaceutical industry for more than 20 years, she has extensive knowledge and experience in Quality Assurance (GCP & GVP & GCLP), Compliance & Training and Clinical Development areas.

Cathy has 12 years of experience of leading teams in clinical operations for local/global clinical trials, managing a group of Compliance & Training advisors to support a full functioning Roche Pharma Development Centre, and conducting GxP audit programs in the areas of GCP/GVP/GCLP in Asia Pacific, Europe & US and developing the audit and inspection strategy for GCP activities for Roche Pharma.

讲者介绍 / About the Speakers

刘海涛 / Heidi LIU辉瑞（中国）研究开发有限公司，担任质量保证中国策略主管

Quality Assurance Lead, Medical Quality Assurance, Pfizer (China) Research andDevelopment Co, Ltd.

自上海医科大学临床医学专业毕业后，于复旦大学附属中山医院从事临床工作。2003年赴澳洲学习，获悉尼大学国际公共卫生硕士学位后，开始介入药物临床研究工作，

为世界卫生组织热带疾病研究与培训特别项目署（WHO/TDR）的临床项目担任临床监

察与稽查工作。2006年作为访问学者赴美国西部伦理委员会（WIRB）学习。自2006年担任FERCAP （亚太地区伦理委员会论坛）医学官员，在亚太地区进行药物临床试

验质量管理规范（GCP）与伦理审查培训及伦理委员会评估工作。2009年至2010年就

职于复旦大学附属华山医院，负责药物临床试验质量管理以及GCP和研究伦理培训工

作。2011年就职于北京大学临床研究所，负责完善北京大学生物医学伦理委员会的建

设，以及北京大学生物医学研究项目的伦理咨询工作和伦理相关的培训项目。2012年开始从事药企临床研究稽查工作。

Graduated from Shanghai Medical University, Heidi had her clinical practice in Shanghai Zhongshan Hospital as a General Physician. She completed her Master Degree of International Public Health in Sydney University in 2004. For the past 13 years, she has been working in the field of clinical trials. This has included experience in pharmaceutical company as clinical monitor and project manager, monitoring and auditing WHO TDR’s projects, medical officer of Forum of Ethical Review Committees in Asian & Western Pacific Region (FERCAP), Training and Compliance Officer in the Clinical Research Institute of Shanghai Huashan Hospital, Fudan University, the Office Director for Peking University Institutional Review Board, mainly responsible for IRB administration, developing and implementing IRB policies and procedures, providing and organizing training activities. She joined industry in 2012 taking the role as quality assurance professional for GCP & PV audit since then.

孙晔 / Lisa SUN百时美施贵宝全球质量保证亚太区全球合规专家

QC Expert, QA Asia Pacific, BMS

Lisa 于知名跨国药企多年历练, 深耕GCP/GVP稽查核查领域十余年, 积累丰富全球相关

经验并专注于亚太, 有FDA, EMA, 以及亚太地区主要药政当局成功核查管理经验, Lisa 是ISO认证的稽查专家, 拥有MD和MPH学历

Lisa has sound working experience with big MNCs in pharmaceutical industry focusing on quality management, auditing, and inspection management. More than 10 years GCP/GVP auditing and inspection management experience worldwide with the main focus in Asia Pacific region. Successfully managed FDA, EMA and other major HA inspections in AP. Lisa is ISO certified lead auditor, has a MD and a MPH degree.

讲者介绍 / About the Speakers

王玉书 / Yushu WANG 强生研发战略运营及医学事务，质量管理部质量控制经理

QC manager in Janssen (China) Research & Development Center, a division of Johnson & Johnson (China) Investment Ltd.

周立萍 / Liping ZHOU 默沙东研发（中国）有限公司亚太区质量保证总监

Director, Quality Assurance, Asia Pacific, MSD R&D (China) Co., Ltd.

Liping有15年的跨国制药企业工作经验. 加入默沙东（研发）有限公司前，Liping就职于拜耳医药保健有限公司全球研发质量保证部门，曾先后从事GCP/GPvP (Good Pharmacovigillance Practice) 稽查 和 药监部门检查的管理工作，足迹遍及亚太及

欧、美地区。从事质量保证工作以来，Liping积极参与中国QA论坛（CQAF）的建设

及质量保证活动, 致力于与业内同仁及专业人士合作，共同推动中国药物临床试验的质

量。Liping 与1999年毕业于北京医科大学（现北京大学医学部）。

讲者介绍 / About the Speakers

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中国

临床研究中的供应商选择, 认证和管理研讨班2017年12月7-8日 | 上海齐鲁万怡大酒店

随着国内各制药公司对新药研发的日益关注，如何选择临床研究的供应

商，确保试验数据的真实规范，以及与各个供应商更有效的沟通，成了摆在医

药研发企业面前的问题。DIA中国将于2017年12月再次召开 “临床研究中的供

应商选择、认证和管理研讨班”，邀请业界资深专家和相关公司负责人进行讲

课。

会议重要日程

供应商选择概述

从sponsor和procurement等的角度，谈谈如何选择供应商。

新型供应商的重要性

介绍临床研究中的小众供应商，分享执行管理中的特点、流程，风险要点等，

增加对小众供应商的了解。

SMO的选择和管理

介绍和分析SMO在中国的现状，包括行业概述、机会、问题和挑战。从供应商

角度和申办方角度分享在SMO的选择和管理经验，并就面临的问题提出解决办

法。

CRO的选择和管理， CRO的资质以及绩效管理的供应商评估工具 制药企业-CRO的关系一直受到重视，供应商关系与绩效管理对外包临床研究至

关重要。会议将概述如何加强战略采购与谈判方面的专业知识，为我们的客户

提供端到端的服务，使我们成为业务目标执行中的重要合作伙伴，并讨论如何

运用采购、质量控制的原则来建立一种机制，使供应商能够提供一流的产品和

服务，并提高供应风险的可管理性，同时增加供应商的可信度。

中心实验室的选择和管理 将基于实验室服务的市场需求及趋势讨论如何选择和管理中心实验室，关注以

下几个方面：

• 来自CFDI稽查的经验

• 中心实验室和诊断实验室在生物标记物检测服务上的异同

• 中心实验室在伴随诊断项目中的角色和责任

数据统计供应商的选择和管理

随着药监局临床数据管理和统计分析法规的强化和完善，国内临床试验数据管

理和统计分析的专业性要求已经和国际水平一致，需要由有经验的专业团队来

执行，数据管理和统计外包的需求很高。如何寻找符合资质并最适合项目需要

的数据统计供应商，同时在项目执行过程中有效监督供应商的工作质量，是项

目成功的关键。将邀请经验丰富的数据管理和统计专家主讲甄选数据管理和统

计供应商是应涉及的技术细节，采用实例模拟的方式请参会人员进行实战练

习。

供应商管理圆桌论坛

组委会成员

会议联系人: Lily WANG邮箱: lily.wang@DIAglobal.org 电话: +86. 21. 6042 9833

报名联系人: 杨文怡

邮箱: Wenyi.yang@diaglobal.org电话: +86. 21 6042 9857

顾娟红阿斯利康（中国）临床研究总监

Fannie LaiSenior Director, Business Development Asia Pacific, PRA Health Sciences

任科药明康德津石医药科技有限公司副总裁

张艳Q Squared Solutions中心实验室副总裁，亚太区总经理

张玥博纳西亚临智（上海）数据科技有限责任公司总裁

参会人员

• 临床项目管理人员• 临床研究规划和战略策划人员• 数据管理专业人员• 临床研究专业人员• 供应商选择人员• 临床研究者和协调员• 临床监查员• 临床质控和质保专业人员• CRO商务发展和市场部人员

会议开放展商和赞助合作机会！

th

Years

Anniversary

2018中国国际药物信息大会暨第十届DIA中国年会The 10th DIA China Annual Meeting2018年5月22-25日 | 北京国际会议中心 May 22-25, 2018Beijing International Convention Center