第一天 9 月 26 日星期三 08:30-08:40 欢迎和介绍 讲员介绍 课程提纲与目标 刘川博士邵蓉教授 08:40-09:25 第 1 节 : 良好临床规范原则本节介绍开展临床试验的基本药政管理要求 法规框架 历史背景 稽查和检查角色 ICH 规范刘川博士 09:25-10:10 第 2 节

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1 GCP 稽查和检查培训课程 管理和实施的最佳实践 9 月 日中国药科大学 中国. 南京 本培训课程将从法规的角度讨论电子临床验证的策略和技术, 如何按照 GCP 的要求准备和实施 GCP 稽查和检查, 并邀请经验丰富的 GCP 检查专家介绍全球 GCP 环境下的药政法规就稽查和检查的要求和规范及如何计划和执行有效的检查程序 学习内容 临床规范原则 稽查计划和策略 稽查的角色 稽查的准备 申办者自查 / 服务商 / 和对第三方的检查 FDA 检查和问题处理 483 表和警告信 比较药监部门在 GCP 检查的要求 参会人员 u 临床研究专业人员 u 临床研究辅助人员 u 质量保障和质量监控专业人员 u 临床稽查员和检查员 u 数据管理专业人员 u 临床项目管理人员 u 临床监查人员 u 药政事物专业人员 u 临床研究者和研究协调员 检查中的问题发现和处理 稽查报告 欺诈行为 对电子临床计算机系统检查 药物清点和临床数据稽查 学习目标 理解 GCP 原则与稽查 / 检查的关系 了解有关质量稽查计划和策略, 以及如何成功制定稽查计划 认识质量稽查的类别, 及其必要性和价值 如何准备稽查, 有效完成稽查 准备临床数据系统的检查和风险评估 认识如何检查药物清点计量和评估外包服务 评估管理系统中的薄弱环节及弥补方案 了解质量保证的稽查程序 组委会主席刘川博士医药数据解决方案公司大中华地区发展总监 组织委员会邵蓉教授中国药科大学国际医药商学院院长 Yolanda L. Taylor 博士礼来公司全球医学质量总监王佳楠国家食品药品监督管理局药品认证管理中心检查一处主管药师 协办单位 中国药科大学 国家食品药品监督管理局信息中心 江苏省药学会 Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA training material in any type of media, is prohibited without prior written consent from DIA. 中国北京海淀区中关村西区海淀东三街 2 号, 欧美汇大厦七层 766 室, 邮编 : 电话 传真 dia@diachina.org

2 第一天 9 月 26 日星期三 08:30-08:40 欢迎和介绍 讲员介绍 课程提纲与目标 刘川博士邵蓉教授 08:40-09:25 第 1 节 : 良好临床规范原则本节介绍开展临床试验的基本药政管理要求 法规框架 历史背景 稽查和检查角色 ICH 规范刘川博士 09:25-10:10 第 2 节 : 稽查的角色 研究基地与系统稽查 监查计划的审阅 研究计划的审阅 稽查计划的准备刘川博士 10:10-10:30 茶歇 10:30-11:30 第 3 节 : 稽查的准备本节概述如何准备和进行 GCP 规范的稽查, 需要评估的方面和如何完成稽查 开展稽查 稽查 - 文档 研究者文档 伦理委员会批准与知情同意书 安全性报告 稽查 - 源数据 病例报告书审阅 记录保留 稽查后活动 关闭 报告和后续跟踪 Yolanda Taylor 博士 13:30-14:15 第 5 节 : 稽查报告本节讨论稽查报告的准备, 在报告处理中所发现的问题及跟踪稽查问题 准备稽查报告 报告分发 管理层的承诺 对稽查报告的回应 稽查活动的文档 14:15-15:30 第 6 节 : 实际条例分析讨论开放式讨论 : 稽查清单 被稽查方如何准备稽查 被稽查方在稽查过程中不应做的事情 稽查政策 15:30-15:45 茶歇 15:45-16:30 第 7 节 : 药监部门在稽查与检查上的比较 监管依据 EMA 监管检查的关键要素 日本监管检查的关键要素 SFDA 与美国 / 欧盟及日本在政策上的相同与不同之处 王佳楠 16:30-17:15 第 8 节 : 研讨练习 准备稽查计划 流程及问题解答 Yolanda Taylor 博士 11:30-12:30 第 4 节 : SFDA 检查和常见问题 一般程序 主要稽查要点 发现的常见问题 药政法规及规范 对 SFDA 检查问题的回应和对策王佳楠 12:30-13:30 午餐

3 第二天 9 月 27 日星期四 08:30-08:40 第二天日程介绍 08:40-09:40 第 9 部分 : 申办者自查 / 服务商 / 支持功能和第三方稽查 本节介绍如何对临床研究服务辅助功能进行稽查, 包括稽查的类别和应关注的问题 申办者自查稽查 QA/QC 角色 稽查和检查 SOP 文件材料和档案材料 系统稽查 稽查 - 临床化验室 化验室证书和执照 化验程序 样本踪迹 存储和留样 QC/QA 记录保留 正常范围 合同研究组织 义务审查 预选稽查 研究程序稽查 契约义务 Yolanda Taylor 博士 09:40-10:40 第 10 部分 : 稽查与问题发现本节研讨实际检查结果和结局的审评, 讨论检查结果对申办方和被稽查方的影响 对观察结果的评议 ( 复合材料 ) 刘川博士 10:40-10:55 茶歇 14:30-15:15 第 13 部分 : 欺诈行为及问题本节阐述临床试验中出现的严重完整性问题的分类, 政府机构在临床研究中的作用 问题的类别 法规和处罚 欺诈的分类 其他政府机构 Yolanda Taylor 博士 15:15-15:30 茶歇 15:30-16:15 第 14 部分 : 电子临床计算机系统检查本节讨论与临床试验中计算机系统稽查有关的主要问题 电子临床系统的检查 电子临床系统类别 监查和稽查临床安全系统 临床试验的计算机系统和数据库 装置软件 硬件和计算机系统验证 系统概貌 流程和验证 接触监控和数据输入 数据库稽查 变更监控和报告 技术服务商检查刘川博士 16:00-17:00 第 15 部分 : 专题讨论问答 Yolanda Taylor 博士 17:00 培训结束刘川博士 10:55-12:00 第 11 部分 : FDA 检查后续活动本节讨论最新 FDA 检查的结果, 解析 FDA 检查结果和不利调查结果的类别 FDA 检查问题发现和解释 对 FDA 检查的回应 FDA 对申办者 / 伦理委员会 / 合同研究组织的检查 法规程序 其他行动 / 处罚 12:00-13:30 午餐 13:30-14:30 第 12 部分 : 药物清点和临床数据稽查了解临床试验中与药物清点计量和临床数据稽查有关的主要问题 药物清点 药物供应的运送 / 处理 盲态与非盲态 日志 药片计数和空瓶退还 数据验证和核对 源文件刘川博士 How Do I Join? Joining a SIAC is easy, convenient, and free as part of your DIA membership. Go to to join the SIACs of your choice. To become a DIA member, go to Worldwide Headquarters Drug Information Association 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Tel Fax Washington D.C. Office th Street, NW, Suite 800 Washington, DC 20006, USA Tel Fax Europe Kuechengasse 16 Postfach 4002 Basel Switzerland Tel Fax Japan Nisso 22 Building 7F Azabudai Minato-ku, Tokyo Japan Tel Fax India A-303, Wellington Business Park I Mumbai , India Tel Fax China DIA (Beijing) Healthcare Information Consulting Ltd. Gateway Plaza, Tower A, Rm No. 18 XiaGuangLi, North Road, East Third Ring Chaoyang District, Beijing, , China Tel Fax Share Best Practices Network with Professional Colleagues Exchange Knowledge Join a SIAC!

4 Training on GCP Regulatory Audit and Inspection Best Practice for Management and Conduction of Regulatory Auditing and Inspection of Pharmaceuticals September 26-27, 2012 China Pharmaceutical University (CPU) Nanjing, China This class focuses on how to prepare and implement regulatory audit and inspections per GCP perspectives. Experienced global inspection experts will give trainees the fundamental knowledge and procedures of regulatory audit and inspection practices and expectations in a global GCP environment. Attendees will also learn how to plan and conduct effective regulatory processes of inspections. Further, the training workshop will illustrate strategic techniques of e-clinical validation from the standpoint of regulatory inspection views. FEATURED topics Principles of Good Clinical Practices Audit Programs and Strategies The Role of the Audit Preparation for the Audit SFDA inspection and Finding The Audit Report Drug Accountability and Clinical Data Audit Audit issues for Sponsor Self/Vendors/ learning objectives Support Functions and Third Party FDA Audits and Findings & Follow-up Review of Inspection Observations Comparison of SFDA/ FDA/EMA Auditing and Inspection Fraud and Misconduct Inspection of e-clinical Computer Systems who should attend u Clinical study professionals u Clinical research associates u Quality assurance and quality control professionals u Clinical auditors and inspectors u Data management professionals u Clinical project management u Clinical monitors u Regulatory affairs professionals u Clinical researchers and study coordinators PROGRAM chairperson Daniel LIU, PhD Director, China Development Medidata Solutions Worldwide, China At the conclusion of this course, participants should be able to: Understand audit/inspect against the principles of GCP Know what are quality audit programs and strategies involved when conducting an effective internal and external quality audit, and how to plan for its successful implementation Learn the types of quality audits conducted, why they are necessary, and the value they provide Be familiar with how to prepare for an audit, achieve closure, and get the best out of your quality audit system Prepare for a clinical data system inspection and assess risk areas that need prioritization Recognize how to inspect drug accountability and to assess outsourcing and third party Review the system for regulatory vulnerabilities and to develop an action plan intended to close those gaps Describe the quality assurance audit process PROGRAM COMMITTEE Rong Shao, Professor Dean, School of International Pharmaceutical Business, China Pharmaceutical University, China Yolanda L. Taylor, PharmD Director, Global Medical Quality, Eli Lilly and Company, USA Jia nan WANG Assistant Pharmacist, Inspection Division I, Center for Certification of Drug, State Food and Drug Administration, China Co-Sponsors China Pharmaceutical University Information Center of State Food and Drug Administration Chinese Pharmaceutical Association Jiangsu Branch Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA training material in any type of media, is prohibited without prior written consent from DIA. 7/F, Room 766, Metropolis Tower I No.2 Haidian Dong San Street I Zhongguancun Xi Zone I Haidian District, Beijing , China Tel Fax dia@diachina.org

5 Day 1 I Monday, September 26 12:30-13:30 Luncheon 08:30-08:40 Welcome and Introduction Introduction of Faculty Background of Participants Course Outline and Objectives Rong Shao, Professor 08:40-09:25 Session 1: Principles of Good Clinical Practices The purpose of this session is to provide the participants with background information on the basic regulatory requirements for the conduct of clinical trials. Regulatory Framework Historical Background Role of Auditing and Inspections ICH Regulations 09:25-10:10 Session 2: The Role of the Audit Site vs. Systems Audit Review of Monitoring Plan Review of Study Plan Preparing the Audit Plan 10:10 10:30 Refreshment Break 10:30 11:30 Session 3: Preparation for the Audit This session will provide the participants with information on how to prepare for and conduct a GCP audit, what issues need to be assessed and how to finish the audit and close-out the audit. Conducting the Audit Auditing Documentation Investigator Files IRBs Approvals and Consent Forms Safety Reporting Auditing Source Data CRF Review Record Retention Post Audit Activities Close-out Reporting and Follow-up 13:30-14:15 Session 5: The Audit Report The purpose of this session is to discuss the preparation of an audit report, how to handle issues identified in the report and how to get management buy-in and follow-up for audit issues. Preparing the Audit Report Distribution of Report Management Commitment Response to Audit Documentation of Audit Activities 14:15-15:30 Session 6: Real-World Practice This session will open an interaction for speakers and attendees to have a Q&A chance. Bucket List of Auditing What Should Auditee Do to Prepare the Auditing What Should Auditee Not Do During the Auditing What Policies for Auditing All speakers 15:30 15:45 Refreshment Break 15:45 16:30 Session 7: Comparison of SFDA/ FDA/ ema auditing and inspection Regulatory Foundation Key Elements of EMA Regulatory Inspection Key Elements of Japan regulatory Inspection Similarity and Differences of SFDA Policies from US/EMA/JP Policies Jianan Wang 16:30-17:15 Session 8: Workshop This session will provide a hands-on exercise on how to develop an audit plan with discussion on audit findings. Developing an Audit Plan Explanation and Process Yolanda Taylor, PharmD Yolanda Taylor, PharmD 11:30-12:30 Session 4: SFDA inspection and Finding General Procedure Key Auditing Elements Common Findings Regulatory Process for Findings Response and Strategy to Sfda Auditing Findings Jianan Wang

6 Day 2 I Thursday, September 27 08:30 08:40 Introduction to Day 2 08:40-09:40 Session 9: AUDIT ISSUES FOR SPONSOR SELF/VENDORS/SUPPORT FUNCTIONS AND third PARTY The purpose of this session is to provide the participants with an understanding of the types of issues and areas of concern when auditing support functions for clinical studies. Sponsor Self Auditing Qa/Qc Role Sop Of Audit and Inspection Documentation and Archive System Audits Auditing - Clinical Labs Lab certification and licensing Lab Procedures Sample trail Storage and retention QC/QA Record keeping Normal ranges CROs Review of Obligations Pre-Selection Audits Study Progress Audits Contractual Obligations Yolanda Taylor, PharmD 09:40 10:40 Session 10: Audits and Findings This session will provide a review of actual inspection observations and outcomes and discuss the implications for the sponsor and the auditee from these inspections. Review of Observations (Composites) 10:40-10:55 Refreshment Break 10:55-12:00 Session 11: FDA inspections Follow-up This session will discuss the results from recent FDA inspections and provide participants with some insight on how to interpret FDA inspection results and the ramifications from adverse findings. FDA Inspecting Findings and Interpretation Response to FDA Inspections FDA Inspections of Sponsors/IRBS/CROs Regulatory Process Other Actions/Sanctions 12:00-13:30 Luncheon 13:30-14:30 Session 12: Drug Accountability and clinical Data Audit The purpose of this session will be to provide participants with an understanding of key issues related to the audit of drug accountability and clinical data audit in clinical trials. Drug Accountability Shipping/Handling of Supplies Blinded vs. Unblinded Diaries, Pill Counts, Return of Empties Data Verification and RecoRnciliation Source Documents 14:30 15:15 Session 13: Fraud and Misconduct This session will provide the participants with information on the types of serious integrity issues that can occur during clinical trials and the implications and outcomes for the persons involved. The session will also highlight the role of other government agencies in clinical research and ensuring the integrity of valid scientific research. Types of Problems Regulatory and Other Sanctions Ramifications of Fraud Other Government Agencies Yolanda Taylor, PharmD 15:15 15:30 Refreshment Break 15:30-16:15 Session 14: Inspection of e-clinical computer Systems The purpose of this session will be to provide participants with an understanding of key issues related to the audit of computer systems in clinical trials. Inspection of e-clinical System Types of E-Clinical Systems Encountered Monitoring And Auditing Clinical Safety Systems Computer Systems And Databases for Clinical Trials Device Software, Hardware and Csv System Overview, Flow and Validation Access Control and Data Entry Database Audits Change Control and Report Inspection of Technology Vendor 16:15 17:15 Session 16: Topics for Discussion Q & A Practicum/Drills Yolanda Taylor, PharmD 17:00 Summary/Wrap Up

7 ABOUT THE SPEAKERS C. Daniel LIU, PhD Director, China Development Medidata Solutions Worldwide, China C. Daniel LIU received his B.Sc. in pharmacy and M. Sc in pharmaceutical chemistry from China Pharmaceutical University, Nanjing, P. R. China and his PhD degree in pharmacology from University of Illinois, USA. Prior to joining pharmaceutical industry, he had more than 10 years of researching experiences in academic environment for drug research and development. He had hands-on experiences in the designing, management and execution of global clinical trials, pharmacovigilance and assembly of regulatory files for the FDA NDA/IND submissions at Novartis, Pfizer, Sanofi-Synthelabo, Schering-Plough and Johnson&Johnson, respectively. Currently, he works as Director of China Development at Medidata Solutions Worldwide. He was the member of the Advisory Council of China DIA and co-chair of Training Committee of ACC DIA China, the member of global training committee of DIA. He has more than 20 researching papers published in professional journals related to pharmaceutical area. Moreover, he is the one of co-authors for several global GCP guidance books Good Clinical Practice: A question and answer reference guide in , and New Drug Approval Process (5th edition), 2009 and so on. He participated to develop the new global GCP guidance Computerized Systems in Clinical Research: Current Quality and Data Integrity Concepts published in His monographic works Clinical Trial Methodology of Medicinal Products was published Mary Ann MORRIS Associate Consultant, Global Medical Quality Eli Lilly and Company, United States is an Associate Consultant in Global Medical Quality at Eli Lilly and Company. During her 18 year career at Eli Lilly she has worked in the Clinical Diagnostic Services and Global Medical Quality functions. While in Clinical Diagnostic Services (CDS), Mary Ann created the quality management system for CDS and developed the Medical-wide Vendor Monitoring program. For her work in CDS, Mary Ann received the Quality Advocate award. While in Global Medical Quality, Mary Ann has partnered with the Global Patient Safety function to ensure regulations and processes related to patient safety are properly included in Medical Quality System documents. Additionally, Mary Ann has served as process owner for the Medical safety mailing process and the Trial Level Safety Review process. Mary Ann received her undergraduate degree in Marketing from Indiana University Bloomington in 1988 and her Doctor of Jurisprudence degree from Indiana University Indianapolis in Mary Ann resides in Zionsville, Indiana, and enjoys spending time with her husband, Kent, and her two daughters, Katy and Kelly. Mary Ann also enjoys reading and scrapbooking.

8 Yolanda L. TAYLOR, Pharm D., Director, Global Medical Quality Eli Lilly and Company, United States Dr. Taylor is the Director of Global Medical Quality at Eli Lilly and Company. During her 17 year career at Eli Lilly she has held various leadership positions in Global Medical Communications, Global Clinical Development, Clinical Project Management, and Global Medical Quality. Yolanda is a trained Lean Six Sigma Black Belt and in 2005 was the recipient of the Six Sigma Rising Star Award. In 2008 she received the Lilly Research Labs President s Award for outstanding scientific achievements in Oncology Clinical Development. Yolanda has been recognized as an honorary member of Worldwide Who s Who for Executives and Professionals and she is a member of the Indiana Healthcare Business Women s Association. She received her undergraduate degree in Biology from the University of Kansas in 1991 and a Doctor of Pharmacy degree from the University of Kansas in When she is not bringing Quality to the workplace, Yolanda enjoys attending her sons various activities, playing volleyball, and running with her dog, Henry. She resides in Carmel, Indiana with her sons, Jonathan and Adam. Jianan WANG Assistant Pharmacist Inspection Division I in Center for Certification of Drug, SFDA, China Jianan WANG now is Assistant Pharmacist, Inspection Division I in Center for Certification of Drug, SFDA, working on China conduct drug GCP/GLP inspection. Prior to SFDA, she worked as research assistant, focusing on medical research of gene function, in Gene research center, School of Basic Medical Sciences, Fudan University. She had been to National Institute of Health Sciences and PMDA, Japan, as visiting scholar, studying for GCP/GLP regulation and inspection system of Japan. She graduated from pharmacology department in China Pharmaceutical University with Bachelor degree and gained Master degree from Pharmacology Department in Peking Union Medical College. She has many publications.

9 DIA 中国 GCP 稽查和检查培训课程会议编码 :# 年 9 月 日中国 南京 会议 / 住宿场所 : 会议 : 中国药科大学, 江苏省南京市童家巷 24 号, 邮编 : 住宿 : 古南都明基酒店, 江苏省南京市鼓楼区玄武门 22-1 号, 邮编 : 电话 : 传真 : 联系方式 : 会议咨询 : 谢飞先生中国北京海淀区中关村西区海淀东三街 2 号, 欧美汇大厦七层 766 室邮编 : 电话 : 传真 : fei.xie@diachina.org or dia@diachina.org 取消注册 : 须在 2012 年 9 月 14 日前 ( 含 9 月 14 日 ) 如需取消注册, 须于规定日期前 ( 含 ) 以书面方式告知 DIA 中国办公室, 并得到 DIA 中国办公室的书面确认, 方可视为取消成功凡已注册并付款者, 若于规定之日前 ( 含 ) 取消注册,DIA 中国办公室将办理退款手续, 手续费人民币 500 元 凡已注册并付款者, 若逾期未办理取消手续, 注册费将不予退还 参会者应自行负责住宿 交通等有关预订及取消的相关费用 预了解更多 DIA 会议信息可登录 会议注册费 ( 含茶歇 午餐及会议资料 ) 企业 会员价 非会员价 ( 会员费 + 会议费 ) 提前注册 (07 月 03 日 -09 月 07 日 ) RMB2000 RMB2900 标准价格 (09 月 08 日 -09 月 14 日 ) RMB2300 RMB3200 现场注册 (09 月 15 日 -09 月 27 日 ) RMB2600 RMB3500 政府机构 / 学术机构 ( 全职人员 ) RMB 1500 RMB2400 * 加入 DIA, 将在一年有效期内享受 DIA 会员服务及会议优惠 索取发票 ( 如需发票, 请填写以下信息 ) 发票抬头 发票金额 人民币 服务项目 会议费 培训费 * 请您到会议现场注册台处领取发票 如您需快递发票, 请填写以下信息收件人地址 收件人姓名 联系电话 团体注册优惠 : 同一公司 5 人同时注册, 第 6 人免费参会!6 人必须在同一时间注册并在会前付款才可享受该优惠 团体注册优惠不与其它优惠共用 点击此处填写团体注册表 ( 第九页 ) ** 会前一周,DIA 将会向成功注册的参会者发送电子版确认函 付款方式 ( 汇率以当日外汇牌价为准 ) 银行汇款请即付人民币 会议编码 #12984 收款人 : 迪亚恩 ( 北京 ) 医药信息咨询有限公司开户行 : 中国银行北京市朝阳支行营业部银行帐号 : SWIFT Code: BKCH CN BJ 110 银行地址 : 北京市朝阳区东三环北路霞光里 18 号佳程广场 A 座一层信用卡支付持卡人姓名 发卡行 信用卡到期日 卡号 安全码 身份证号码 维萨卡 万事达卡持卡人签名 * 请注意目前只接受下列信用卡 : 境外信用卡 : 维萨卡和万事达卡境内信用卡 : 中国银行, 中国建设银行, 中国工商银行, 广东发展银行, 兴业银行, 华夏银行 现场 POS 机支付 ( 需按照现场价格付款 ) 单位类别 制药企业 政府部门 学术单位 外包服务研究机构 /CRO 请填写下表并保持字迹清晰姓 名 职位 称谓 : 先生 女士 教授 博士 单位 ( 公司 ) 名称 ( 英文 ) 中文地址 ( 请注明地址以便今后能正确邮寄 ) 英文地址 省份及城市 国家 邮政编码 公司地址 家庭地址 电话 传真 手机 ( 必填 ) 电子邮件 ( 必填, 以便通过电子邮件发送确认 ) 如果您传真或邮寄报名表, 请提供您的名片或名片复印件

10 Training on GCP Regulatory Audit and Inspection Event I.D. # September 26-27, 2012 Nanjing, CHINA venue AND HOTEL Venue: China Pharmaceutical University(CPU) Address: No.24 Tongjiaxiang, Nanjing, , China Hotel: Grand Metro Hotel Address: No22-1, Xuanwumen, Gulou District., Nanjing, ,China Tel: Tax: Drug Information Association China office 7/F, Room 766, Metropolis Tower, No.2 Haidian East Third Street, Zhongguancun Xi Zone, Haidian District, Beijing, , China Tel: Fax: fei.xie@diachina.org or dia@diachina.org CANCELLATION POLICY: On or before September 14, 2012 Cancellation must be made in writing and received by September 14, 2012, in order to receive the refund. A cancellation processing fee of RMB will be deducted from the refund for each paid registrant. No refund if the written cancellation is received after September 14, 2012 Registrant will be responsible for his own travel, hotel reservation and cancellation expenses For more meeting details Please visit Registration Fees for Conference (Registration fee includes Coffee Breaks, luncheons) Industry Member Non-Member (1 Year Membership+Meeting) Industry Early-bird* (July 03 - Sept 07) RMB2000 q RMB2900 q Industry Standard (Sept 08 - Sept 14) RMB2300 q RMB3200 q Industry Onsite (Sept 14 - Sept 27) RMB2600 q RMB3500 q Nonprofit/Academia/Government (Full-time) RMB1500 q RMB2400 q * Join DIA now to qualify for the member service and discount! REQUEST CHINESE OFFICIAL INVOICE (FAPIAO) q Yes q No Fapiao Title Amount Charged (RMB) Service Item Meeting Fee Training Fee *Fapiao will be provided onsite. Recipient Address Recipient Phone GROUP DISCOUNTS* Register 5 and receive a complimentary registration for the 6th! All 6 individuals must register and prepay prior to the event no exceptions. Group registration does not apply to the already-discounted fees for government or charitable nonprofit/academia. Click Here or go to page 9 to complete the group registration Form ** The confirmation letter will be sent to the registered participants one week prior to the event. PAYMENT * Payment in other currencies will be subject to the financial institution s exchange rate q Bank Transfer: Payment in the amount of RMB Meeting I.D. #12984 Payee: DIA (Beijing) Healthcare Information Consulting Limited Bank Name: Bank of China, Beijing Chaoyang Sub-branch Banking Dept. Bank Account: SWIFT Code: BKCH CN BJ 110 Bank Address: 1st Floor, Tower A, Gateway, No.18 Xiaguangli, North Road, East Third Ring, Chaoyang District, Beijing, , P.R.China q Credit Card Payments By: Cardholder Name Card Issue Bank Exp. Date (mm/yyyy) Card # Security Code ID # q Visa q Master Card Signature * Only following cards are accepted: Foreign Credit Card: VISA & MasterCard. Domestic Credit Card: Bank of China, China Construction Bank, Industrial and Commercial Bank of China, Guangdong Development Bank, China Industrial Bank, Huaxia Bank. q POS Terminals Machine Payment (Onsite Price) Please check the applicable category: q Industry q Government q Academia q CSO/CRO Please Print All Information Clearly Last Name First Name M.I. Full Name in Chinese (If applicable) Please check one: q Mr. q Ms. q Prof. q Dr. Job Position Affiliation (Company) q Business Address q Home Address Address (Please write your address in the format required for delivery to your country.) City Postal Country/Region Address in Chinese (If applicable) Telephone Number Fax Number Mobile Number (Required) (Required for confirmation) IF FAXING OR MAILING THIS FORM, PLEASE PROVIDE A COPY OF REGISTRANT S BUSINESS CARD.

11 Group Registration Form 团体注册表 Training on GCP Regulatory Audit and Inspection September 26-27, 2012 Nanjing, China 团体注册优惠同一公司 5 人同时注册, 第 6 人免费参会!6 人必须在同一时间注册并在会前付款才可享受该优惠 团体注册优惠不与其它优惠共用 GROUP DISCOUNTS Register 5 and receive a complimentary registration for the 6th! All 6 individuals must register and prepay prior to the event no exceptions. Group registration does not apply to the already-discounted fees for government or charitable nonprofit/academia. 公司名称 (Company Name) 中文地址 (Chinese Address) 英文地址 (English Address) 省份 (Province) 国家 (Country/Region) 邮政编码 (Postal) (1) 注册费 (Registration Fee): 姓 (Last Name) 名 (First Name) 职位 (Title) 中文名 (Chinese Name) 称谓 : 先生 (Mr.) 女士 (Ms.) 教授 (Prof.) 博士 / 医师 (Dr.) 电话 (Tel) 传真 (Fax) 手机 (Mobile) (2) 注册费 (Registration Fee): 姓 (Last Name) 名 (First Name) 职位 (Title) 中文名 (Chinese Name) 称谓 : 先生 (Mr.) 女士 (Ms.) 教授 (Prof.) 博士 / 医师 (Dr.) 电话 (Tel) 传真 (Fax) 手机 (Mobile) (3) 注册费 (Registration Fee): 姓 (Last Name) 名 (First Name) 职位 (Title) 中文名 (Chinese Name) 称谓 : 先生 (Mr.) 女士 (Ms.) 教授 (Prof.) 博士 / 医师 (Dr.) 电话 (Tel) 传真 (Fax) 手机 (Mobile) (4) 注册费 (Registration Fee): 姓 (Last Name) 名 (First Name) 职位 (Title) 中文名 (Chinese Name) 称谓 : 先生 (Mr.) 女士 (Ms.) 教授 (Prof.) 博士 / 医师 (Dr.) 电话 (Tel) 传真 (Fax) 手机 (Mobile) (5) 注册费 (Registration Fee): 姓 (Last Name) 名 (First Name) 职位 (Title) 中文名 (Chinese Name) 称谓 : 先生 (Mr.) 女士 (Ms.) 教授 (Prof.) 博士 / 医师 (Dr.) 电话 (Tel) 传真 (Fax) 手机 (Mobile) (6) 请将免费参会人信息填写在下列表格中 (Pleasse complete following personal information for complimentary discount) 姓 (Last Name) 名 (First Name) 职位 (Title) 中文名 (Chinese Name) 称谓 : 先生 (Mr.) 女士 (Ms.) 教授 (Prof.) 博士 / 医师 (Dr.) 电话 (Tel) 传真 (Fax) 手机 (Mobile)