孙华龙 医学博士

美达临床数据技术公司总经理

孙华龙，日本东京大学医学研究医学博士，DIA中国顾问委员会理事成员，中国临床数据管理学组（CDMC）成员，中国医疗器械行业协会数据分析专业委员会委员，近20年临床开发经验，曾就职于默克雪来诺，PAREXEL等跨国药企和CRO, 先后担当生物统计，数据管理，项目主管，数据管理等部门负责人，在肿瘤，泌尿生殖，心血管，免疫等治疗领域的临床试验都有丰富的经验，先后在DIA组织领导多场数据管理，文档管理等培训活动，深受参会者喜爱。

刘川 博士

北京科林利康医学研究有限公司首席科学官

刘川博士，曾任CFDA药审中心临床试验数据标准化工作指导组核心成员，DIA全球培训理事会理事，DIA中国临床试验数据管理学术沙龙负责人，中国临床试验数据管理学组副组长，CFDA高级研修学院客座教授，美国临床数据管理协会（SCDM）中国区指导委员会委员，现就职于北京科林利康医学研究有限公司，任首席科学官。曾就职于诺华，辉瑞，赛诺菲，先灵葆雅，强生，Medidata等跨国药物公司的全球临床研究部门，从事全球临床试验管理和运营等工作20余年。近六年来在国内外讲授临床相关课程80余场次，组织和参加过DIA举办的年度会议，各类数据管理，临床运营和安全性监督等GCP相关主题培训10余场，主编《药物临床试验方法学》，参与国际GCP补充指南《Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts》的编写工作；国际GCP指南丛书《Good Clinical Practice: A Question and Answer Reference Guide》特约撰稿人，合编《New Drug Approval Process》等书籍，并在国内外专业期刊发表论文20余篇

Titus MODSCHING

德国精鼎监管解决方案和客户支持部业务分析师

SUMMARY OF EXPERIENCE:  Detailed regulatory tracking and publishing know-how with focus on software implementation and upgrade projects  SOP & Process Development, business-requirements analysis  Detailed knowledge of entire RIM (LIQUENT Insight Suite) platform products  Implementation / Upgrade: System Setup -, Business Process - Workshops  Customized training design & Train-the-Trainer / Core-Team workshops  Planning and Schedule of employee training curricula PROFESSIONAL EXPERIENCE: Business Analyst, Client Enablement, Regulatory Solutions, PAREXEL International GmbH, Berlin, Germany May 2013 - Present  Since September 2017: LIQUENT InSight Workflow Integrations implementation project at TIER 2  July – August 2017: LIQUENT InSight Suite Upgrade - TIER 2 – System Setup Workshop & support  November 2016 – February 2017: LIQUENT InSight Publisher Upgrade - TIER 2 – System Setup Workshops & implementation support  May 2016 – July 2018: LIQUENT InSight Suite Implementation - TIER 1 – Requirements & System Setup Workshop, Core-Team Training, template-work, special team workshops, implementation support  June-September 2016: TIER 1 SPT Upgrade; System Setup & Business Process Workshop  March – May 2016: IDMP Gap-Analysis Workshop at a TIER 2 company  February 2016 – July 2017: LIQUENT InSight Publisher Implementation at TIR 1 – Requirements Analysis, Business Process & System Setup Workshop, Core-Team Training & implementation support  February/March 2016: LIQUENT InSight Registrations Upgrade - TIER 2 – System Setup Workshop  June 2015 – December 2016: LIQUENT InSight Publisher Implementation - TIER 1 – Requirements workshop, System Setup Workshop, Core-Team Training, Train-the-Trainer, template-work  July – December 2015: LIQUENT InSight for Registrations Implementation project - TIER 3 – Regulatory Tracking Analysis, Core-Team Training and System Setup Workshop  April – December 2015: TIER 2 IDMP project – process development, set-up implementation process  November 2014 – January 2015: eCTD import project - TIER 2  September 2014: Regulatory/Training Workshop InSight Publisher/Registrations - TIER 3  July 2014: System Setup Workshop for InSight Publisher implementation - TIER 3  March – September 2014, TIER 1 - gCTD import project  January - March 2014, TIER 2 - GRATIS regulatory tracking implementation: Core Team Training, Data Gathering (Administration) support, Train-the-Trainer  January 2013 – January 2014, TIER 2 – Core Team Training for entire InSight platform, Train-the-Trainer, training material customization Senior Instructional Designer/Trainer, Liquent Ltd., Education Services, Munich, Germany April 2010 – April 2013  Lead of EU wide trainings for InSight Suite / training center Munich  January – May 2013, EU implementation lead TIER 2 regulatory tracking, Power Users & Trainers  January – August 2012, Application consultant for system setup workshops – TIER 3 (InSight for Registrations)  September – December 2011, Development of client specific SOPs - TIER 1  August – September 2011, Project lead rollout/upgrade RIM trainings, business process design TIER1 Instructional Designer/Trainer, Liquent Ltd., Education Services, Munich, Germany April 2008 – March 2010  Lead of EU wide trainings for InSight Suite / training center Munich  Coordination and execution of product & software trainings for Liquent InSight  Project lead rollout training InSight for Registrations at TIER 2  Development of client specific SOPs for TIER 2 and conduction of customized training Deputy Team Manager Systems & Data, Sales & Marketing Academy, O2 Germany, Munich November 2002 – January 2008  Lead of planning for all trainings at O2 Germany  Coordination and execution of product, software and soft-skills trainings at O2 Germany  Performed trainings and consulting for service providers  January 2006 – January 2008, Project lead training & OQ, Sales & Marketing Academy –CRM-implementation Senior employee, technical back office, data cleansing, VIAG Interkom February 1999 – October 2002: EDUCATION:  Continuous internal training according to PAREXEL training schedule (e.g. GMP, Regulatory, Clinical)  DIA & EMA, London: eXtended EudraVigilance Medicinal Product Dictionary Training Course (XEVMPD), March 2012  DIA, Prague – European Regulatory Affairs: In-depth review of current registration procedures, October 2010  Trainer-certification PE Support (e.g. learning, coaching, communication, neuro-linguistic programming, transactional analysis, education-methods), August 2006 – February 2007  Basic principles of project-management I, II (O2 Germany) Structogram® training system, Coaching (O2 Germany), June – October 2006  Certified as Instructional Trainer O2 Germany (Grundig Akademie), April 2003  Master of Business Administration (BA), Ravensburg - Germany, December 1998  education of vocational instructors (AdA) - Chamber of Commerce and Industry‘s instructor certification (IHK), Ravensburg – Germany, October 1997  School leaving examination (A-levels), Neumarkt – Germany, July 1993

吉申齐

辉瑞（中国）研究开发有限公司全球药品法规运营注册出版与药品许可支持部亚太区药品注册文件出版负责人

Handsome Ji started in the Pharmaceutical industry in 2006 as a Clinical Study Report Coordinator/Publisher at Pfizer. After 3 years’ working experience in Clinical Operations, Handsome moved to Regulatory Operations team as a Regulatory Submission Specialist. In 2012, Handsome was appointed as APAC Publishing Lead directing a team which is responsible for publishing CMC Dossiers, Clinical Study Reports and Regulatory Submissions, this team works on the CMC Reports, Clinical Study Reports from Phase I to IV and regulatory submissions across all regions during all stage of a product lifecycle. Handsome has considerable project and operations experience, has developed and implemented strategies resulting in operational excellence and process efficiencies. He is highly driven and experienced, with 12 years operational, project and change management experience within multi-cultured global environments. Handsome was invited as guest speaker in DIA China 7th Annual Meeting, served as host and Speaker for CMWC (China Medical Writing Community) forum in 2015 and 2016 and Workshop leader for eCTD Masterclass in 2016 China Regulatory Summit. Recently, Handsome has been invited as China DIA Young Member of Advisory Council (YMAC) in March 2018. Handsome holds bachelor degree in Computer Science from Fudan University.

孙家庚

辉瑞（中国）研究开发有限公司全球药品法规运营注册出版与药品许可支持部药品注册文件出版团队主管 (成熟市场- 北美及欧盟)

Bruce joined Pfizer from 2012 as role of Publishing Manager supporting publishing activities of Regulatory Submissions and Clinical Study Reports (CSR) across Pfizer global markets. In 2018, Bruce was appointed as Publishing Team Lead focusing on eCTD submissions of Pfizer Established Markets (US/Canada/EU). Bruce has profound knowledge of eCTD standards, system expertise and regulatory operational experiences across markets and led multiple critical eCTD transition projects within Pfizer in APAC region (Thailand eCTD: 2015; China eCTD: 2017-now). He was also invited as guest speaker at various industry association conferences or forums. -7th Pharma Regulatory Affairs conference (2014) -CMWC forum(China Medical Writing Community) (2015-2017) -eCTD Masterclass in Regulatory Summit China (2016) -RDPAC Annual Meeting  (R&D based Pharmaceutical Association Committee) (2017) Bruce holds a bachelor’s degree in Bioinformatics from Shanghai Jiao Tong University.