胡蓓   医学博士、教授      

北京协和医院临床药理中心临床药理学教授，临床药代药效研究北京重点实验室主任

缔脉生物医药科技（上海）有限公司，统计分析高级经理

王怡勤

系统解决方案经理，缔脉生物医药科技（上海）有限公司

个人简介:负责提供eCTD相关系统及服务解决方案；曾在辉瑞负责药品注册出版与许可支持工作，支持辉瑞全球市场的药品注册文件以及临床试验研究报告文件出版和递交。作为辉瑞eCTD出版及管理系统管理员和药品注册eCTD 论题专家，参与出版系统变更项目且有7年以上eCTD出版经验。高研院eCTD相关专题讲者。

演讲主题：Digitization of Regulatory Operation Excellence

话题简介：Regulatory and submissions are essential for the communication with regulatory agencies. Within the entire product lifecycle from clinical trial application, marketing authorization to maintenance, submissions require the collaboration of multiple function lines to complete the regulatory strategy determine, nonclinical, clinical and CMC documents authoring and lifecycle management. Along with the eCTD relevant policies were released to public, CDE is going to retire the traditional paper submission to utilize the same technology as the established markets. How we can prepare ourselves to follow agencies’ higher review standard, address the issues happened during the transition period and smoothly move to eCTD fully implemented with technical solutions. With the globalized eCTD transition progress, how to improve the efficient and be cost effective.

梁铮

药品注册文件出版项目经理，辉瑞（中国）研究开发有限公司

个人简介:主要负责全球运营注册出版项目的综合管理，整合辉瑞内部出版、注册、信息管理以及技术专家在内的项目成员，确保项目在成员共同协作之下按计划顺利完成，同时也领导亚太地区其他出版成员小组，支持辉瑞市场所涉及的注册文件出版工作。 

演讲主题：Prepare Upcoming China eCTD Implementation – Our Current Situation and Future Prospection

话题简介：Starting from ICH CTD acceptance, looking into eCTD adoption trend, what’s our strength and challenges in implementation? Tracking back from China M4 & M8 milestones, how will China implement eCTD in the near future? Based on the latest guidance, what’s the main highlights and future prospection of China eCTD?

黄杰

产品管理经理，摩亦（上海）医药技术有限公司

演讲主题：谈eCTD格式电子申报

话题简介：概要性的介绍eCTD技术规范和验证标准; eCTD和CTD二者之间的差别; eCTD和eTMF的内在联系; eCTD产品的技术要求。

陶晓俊

药物安全系统支持部门中国团队负责人，辉瑞（中国）研究开发有限公司

个人简介:药物安全警戒系统专家，负责管理公司全球药物安全系统，及相关的数据仓库，数据分析平台和周边系统的建设和日常支持。任中国团队负责人，长期与业务部门紧密合作，致力于通过技术应用，系统整合和流程改进来促进各业务部门的工作效率和工作质量。

演讲主题：E2B技术标准概览和实践

话题简介：概述ICH E2B标准的基本内容，业务需求和实施模型。介绍E2B R2 和 R3在国内的实践经验，探讨电子化数据提交实施背景下，企业所需建立的系统及业务能力。

郭子菁

统计分析师，缔脉生物医药科技（上海）有限公司

个人简介:主要负责临床数据的SAS编程工作，即根据项目的需求，分析需求并编写SAS程序，以在计划时间内产生高质量可交付的数据结果。毕业于武汉大学公共卫生学院预防医学专业。

演讲主题：Define.xml Links Validation

话题简介：This presentation demonstrates some approaches to validate the links inside the Define.xml. XML file can be rendered into HTML web page file. Inside HTML web page file, there are two types of links, links to internal anchors, and to external files. CRF pages are special links to PDF file pages. There are many tools to validate those two types of links. But for CRF Pages, how do we validate them? Join our session to check out.

吕凯

临床一体化产品线副总裁，深度智耀

个人简介:在深度智耀领导负责临床一体化产品开发，利用丰富行业经验，结合AI技术，打造自动写作、自动翻译、自动出版及报批一体化智能平台，曾在拜耳担任全球医学写作运营负责人，领导德国、美国、中国与芬兰医学写作团队；领导拜耳全球注册报批与文件管理系统、全球eTMF管理系统的搭建及运营；拥有15年以上eCTD电子报批经验。美国伦斯勒理工学院工商管理硕士。

演讲主题：When Professionals Meet Intelligence ——Compliance processing of eCTD dossier using Intelligent solutions

话题简介：On September 17, CDE Published the second edition of the Guidelines for eCTD(Draft for Consultation). It is expected that eCTD will be implemented by the end of 2019.Traditional solutions for eCTD only provide simple tools like writing template or compiling and publishing system, but fail to achieve close-loop and integration of writing, translation, eReadiness check, publishing and submission. When using these traditional systems, operators should manually check and fix hundreds of hyperlinks, compile hundreds of documents. These repeated and complicated work increase time cost of eCTD preparation, and inevitably accompany various problems due to lack of experience. When meeting AI technology, how to deal with writing, eReadiness check, and publishing more intelligently and automatically? How to liberate RA from the boring work and make them focus on more important affairs? When eCTD Meets AI, what kind of transformation will happen?  Please look forward to Intelligent solutions for eCTD Developed by Deep Intelligent Pharma.