Thank you for attending the 2018 China Interchange. You will find a link to each of the presentation slides from the event below.
Session 1: Opening Plenary & Keynotes
Opening Remarks
David R. Bobbitt, CDISC President and CEO; and David Hardison, CDISC Board Past-Chair
Keynote Presentation - Data Standardization from a Statistical Review Perspective
Jun Wang, CDE (NMPA)
U.S. Regulatory Update
Ron Fitzmartin, FDA-CDER
Japan Regulatory Update
Yuki Ando, PMDA
Session 2: The Past, Present & Future of CDISC Standards
Global Standards for a Greater Impact on Global Health
Peter Van Reusel, CDISC CSO
SHARE 2.0
Sam Hume, CDISC VP, Data Science
CDISC Myths & Truths: Creating Clarity
Bess LeRoy, CDISC Head of Standards Development
Session 3: Submission Update from CNDA
Data Submission in China: Current Status and Future
Victor Wu, C3C
Data Standardization Implementation in China Study - Practice and Proposal
Chao Wang & Shenglin Zhang, C3C
Session 4: Compliance & Regulatory Topics
ADaM Standards - Implementation, Challenges and FAQs
Guowei Wu, MSD
CDISC Conformance Checking Introduction and Implementation
Jialei Zhang, dMed
Traceability of Study Data from Collection Through to Analysis
Jason Guan, Novartis
Session 5: Intro to CDISC Standards & User Group Updates
Update on C3C Achievements, User Groups and Workgroups
John Wang, C3C
Japan CDISC Coordinating Committee (J3C) Update
Yoshiteru Chiba, J3C
Update of CDISC CDASH 2.0
Lily Zhao, PAREXEL
Session 6: Panel Discussion
Session 7, Track A: Use Cases for CDISC Standards & Technology
The WHODrug B3/C3 Formats and CDISC SDTM Compliance
Damon Fahimi, UMC
Best Practices for Increasing Accuracy and Efficiency of Database Build
Tianjiao Li, FMD K&L
Implementation of Trial Design Model (TDM) in Adaptive Trial Design
Song Gao, Jiangsu Hengrui Medicine Co., Ltd.
Good Practices for FDA/PMDA Define Package Preparation
Jia Yang, Novartis
Session 7, Track B: Process, Efficiency and Tools
Intelligent Assessment and Expansion of Clinical Trial Data in CDISC Format
Wenjun Bao, JMP Life Sciences
Optimizing SDTM Process by Tool Invention: Define-XML Creator and SDTM Validator in China
Ruiling Peng, Improve-Quality Medical
ADRG Automation Using R Markdown
Minhan Li, dMed
How to report SAE/ADR data with E2B R3 format
Song Li, ForceClouds
Session 8, Track A: Use Cases for CDISC Standards & Technology
Frequently Asked Questions in CDISC Implementation
Victor Wu, Data Science Express
Introduction of SAS Clinical Standards Toolkit
Yaohua Huang, Data Science Express; and Qinghua Wang, SAS Institute
Implementation of CDISC Standard in the PK Data Analysis
Billy Xin, Mosim Medical
Automation of Statistical Analyses Based on ADaM
Xiang Liu, Hua Medicine
Session 8, Track B: Process, Efficiency and Tools
Optimized SDTM Process and Submission Package Preparation with Pattern Macro
Zhenglong Tian, PAREXEL
Mapping the Company’s Legacy Data Model to CDISC
Dawei Zheng, Medidata
Automatic Conversion of the Raw Data to SDTM by Using SAS & VBA
Danjjie Wang, TrustCRO
An Efficient Way to Generate, Update and Maintain Define-XML 2.0
Yuan Wang, FMD K&L
Session 9, Part I: CDISC Standards for Therapeutic Areas
eSubmission Package Preparation for US FDA/Canada HA
Yanhong Li, MSD
Applicability Analysis of CDISC Standards to Clinical Evaluation Data in Guidance for IND of TCM Clinical Research
Joy Li, Xiyuan Hospital
The Development of the Acupuncture Therapeutic Area Standard
Geng Li, KUMCR, Guangdong Provincial Hospital of Chinese Medicine
Implementation of the Time-to-Event Model in Analysis of Clinical Trials
Hongfang Zhou, Jiangsu Hengrui Medicine Co., Ltd.
Session 9, Part II: Therapeutic Areas, Traditional Chinese Medicine & SEND
Updates on TCM-CAD-Angina TAUG and SDTM Standards in Therapeutic Area for Kidney Transplant
Jordan Li, NIH, NCI-EVS
Example on SDTM and ADaM Standards in Neuroscience Therapeutic Area for Major Depressive Disorder
Ella Cheng, Johnson & Johnson
Beginning to End Standards and Therapeutic Areas Projects
Bess LeRoy, CDISC Head of Standards Development
SEND- History, Current Development, and The Vision
Lou Ann Kramer, CDISC Senior Director, Standards Development