Thank you for attending the 2019 China Interchange. You will find a link to each of the presentation slides from the event below.
Session 1: Opening Plenary & Keynote Address
Opening Remarks
David R. Bobbitt, CDISC President and CEO
Welcome Address
Dr. Douglas Peddicord, CDISC Board Chair
Keynote Presentation - Data Standardization from a Statistical Review Perspective
Dr. Zhengqing Li, Merck, CDISC Board of Directors
CDISC Standards Development Update and the New CDISC RWD Connect Initiative
Rhonda Facile, CDISC
Session 2: Second Plenary - CDISC 360
CDISC 360 Introduction and CDISC Library Update
Anthony Chow, CDISC
Session 3, Track A: CDISC Implementation Dictionary, Automation
MedDRA: Safety Data Analysis and SMQs
Joy Zhu, MedDRA MSSO
Moving Box Method for EDC to SDTM Normalization
Kathy Liang, dMed
How to get the balance between quality and efficiency by using semi-automatic SDTM programming
Fengqing Li, Improve-Quality
The Introduction of Global SAS Macros Management Platform Creation Developed with Javascript for CDISC Projects
Haibo Wang, GCP ClinPlus
Session 3, Track B: SEND
Implementation on SEND Standard by CRO
Xiaoyu Xie, Siyi Li, GLPCD
Standard for Exchange of Nonclinical Data (SEND) Implementation
Bei Zhou, Wuxi Apptec
Introduction of SDTM Implementation in Medical Devices Study
Yaohua Huang, Data Science Express
Pharmacokinetics Data Processing in Mass Balance Studies
Zhihao He, CR MedIcon
Session 4, Track A: Drug Safety
Essential PV Knowledge for DM
Minshi Su, Xuanzhu Pharma
Automation of Subject Safety Narratives using ADaM and SDTM Datasets
Jian Shen, S&M Systems
WHODrug – the basics and the news
Damon Fahimi, Uppsala Monitoring Centre
Following E2B, data integration between EDC and PV system
Allison Zhang, Taimei Technology
Session 4, Track B: CDISC Implementation CDISC 360
Common Problems and Solutions of Data Standardization using CDISC Standard in Chinese Clinical Study
Mianmian Guo, GCP ClinPlus
CDISC360 participation and concept practice
Haiping Yu, dMed
Define.xml validation check
Kai Zhou, Johnson & Johnson
Basic consideration in conducting project using electronic Clinical Outcome Assessment (eCOA)
Xueyao Cen, Signant Health
Session 5: Regulatory Presentations
FDA Presentation
Dr. Lisa Lin, FDA-CBER
FDA Presentation
Dr. Matthew Whittaker, FDA-CDER
FDA Presentation
Dr. Alan Shapiro, FDA-CDER
PMDA Presentation
Dr. Daisuke Iwata, PMDA
Session 6, Track A: CDISC Implementation ADaM
Implementation of ADaM Standard in Multiple Imputation
Jia Yang, Novartis
Design and Develop Efficacy ADaM in Multiple Myeloma Studies
Liang Zheng, CR MedIcon
RECIST 1.1/irRECIST criteria and their implementation in ADaM
Hannah Wan, Beigene
Too Soon! ADaM Data Structures for Integration - A Case Study
Clio Wu, FMD K&L
Session 6, Track B: Real World Data
Government-led standardized data collection in large hospitals brings opportunities for clinical research
Hongwei Cai, The first Affiliated Hospital of Xi'an Jiaotong University
Leverage Standardized Real-World Data for Accelerating Development of the Medical Device Trial
Billy Xin, Benemae Pharma
The Core of Healthcare Data Governance: Data Standardization
Yuzhong Zha, OMAHA
Research & Development of Data Visualization System based on CDISC Standard
George Xiang, TrustCRO
Session 7, Track A: Towards End-to-End Automation
Informationization and AI analysis in Clinical Trial Data
Xueqing Jiang, BioKnow
Exploration of Medical Database Standards in China and Introduction of Examples
Bo Chao, LinkDoc
Transformation between CDASH and SDTM in EDC system
Joey Wang, Meta Clinical
Session 7, Track B: CDISC Implementation Trial Design
Beginner's approach to learning the CDISC standards and recommendations
Kuishou Yu, TrustCRO
Best Practice of Trial Summary (TS) Development
Ling Chen, FMD K&L
Implementation of OE domain in Ophthalmic Studies
Zhizhuo Zhang, Novartis
Session 8: Closing Plenary
Tools used to help create/validate eSubmission Packages
Sherry Chou, PAREXEL
The importance of standardization: Viewing from the FDA reviewer's promotion requirements
Wenjun Bao, JMP Life Sciences
Thoughts on SDTM implementation in TCM Study data
Victor Wu, Data Science Express
Consideration on the maintenance of Controlled Terminology of TCM syndromes and drugs
Fang Lu, Xiyuan Hospital