Program of events is subject to change.

19 Sep 2019

Session 1: Opening Plenary & Keynote Address

Victor Wu, C3C Chair
Ballroom III
09:00 - 10:45

Opening Remarks

David R. Bobbitt, CDISC President and CEO

Welcome Address

Dr. Douglas Peddicord, CDISC Board Chair

Keynote Presentation

Dr. Zhengqing Li, Merck, CDISC Board of Directors

CDISC Standards Development Update and the New CDISC RWD Connect Initiative

Rhonda Facile, CDISC

Break

Ballroom II
10:45 – 11:15

Session 2: Second Plenary - CDISC 360

David R. Bobbitt, CDISC President and CEO
Ballroom III
11:15 – 12:15

CDISC 360 Introduction and CDISC Library Update

Anthony Chow, CDISC

Lunch

Beijing Bistro
12:15 - 13:15

Session 3, Track A: CDISC Implementation Dictionary, Automation

Pamela Chen, C3C
Ballroom III
13:15 - 14:55

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

Shenglin Zhang, C3C
Salon 1
13:15 - 14:55

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

Break

Ballroom II
14:55 - 15:25

Session 4, Track A: Drug Safety

Lily Zhao, C3C
Ballroom III
15:25 - 17:05

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

Billy Xin, C3C
Salon 1
15:25 - 17:05

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
20 Sep 2019

Session 5: Regulatory Presentations

John Wang, C3C Vice-Chair
Ballroom III
09:00 – 11:00

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

Break

Ballroom II
11:00 – 11:30

Session 6, Track A: CDISC Implementation ADaM

Stanley Wei, C3C
Ballroom III
11:30 – 12:20

Implementation of ADaM Standard in Multiple Imputation

Jia Yang, Novartis

Design and Develop Efficacy ADaM in Multiple Myeloma Studies

Liang Zheng, CR MedIcon

Session 6, Track B: Real World Data

Dr. Lu Fang, C3C
Salon 1
11:30 - 12:20

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

Lunch

Beijing Bistro
12:20 – 13:20

Session 6, Track A: CDISC Implementation ADaM

Stanley Wei, C3C
Ballroom III
13:20 – 14:10

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

Dr. Zehuai Wen, C3C
Salon 1
13:20 – 14:10

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

Ruiling Peng, C3C Vice Chair
Ballroom III
14:10 – 15:30

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

Hongwei Cai, C3C
Salon 1
14:10 – 15:30

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

Break

Ballroom II
15:30 - 16:00

Session 8: Closing Plenary

Zibao Zhang, C3C
Ballroom III
16:00 - 17:30

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

Closing Remarks

Victor Wu, C3C Chair