Program of events is subject to change.

19 Sep 2019

Session 1: Opening Plenary & Keynote Address

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

Opening Remarks

David R. Bobbitt, CDISC President and CEO

Welcome Address

Dr. Douglas Peddicord, CDISC Board Chair

Keynote Presentation

Zhengqing Li, Merck, CDISC Board of Directors

CDISC Standards Update

Amy Palmer, CDISC

Break

10:45 – 11:15

Session 2: Second Plenary - CDISC 360

11:15 – 13:00

CDISC 360 Introduction

Rhonda Facile, CDISC

CDISC Library Update

Anthony Chow, CDISC

Lunch

13:00 – 14:00

Session 3, Track A

14:00 – 15:40

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

14:00 – 15:40

Implementation on SEND Standard by CRO

Xiaoyu Xie, Siyi Li, GLPCD

Standard for Exchange of Nonclinical Data (SEND) Implementation

Bei Zhou, Wuxi Apptec

Pharmacokinetics Data Processing in Mass Balance Studies

Zhihao He, CR MedIcon

Break

15:40 – 16:10

Session 4, Track A

16:10 – 17:50

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

16:10 – 17:50

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)

Michael Qin, Signant Health
20 Sep 2019

Session 5: Regulatory Presentations

09:00 – 11:00

NMPA Presentation

TBD

FDA Presentation

Dr. Lisa Lin, FDA-CBER

FDA Presentation

Helena Sviglin, FDA-CDER

PMDA Presentation

TBD

Roundtable Discussion

All regulatory representatives

Break

11:00 – 11:30

Session 6, Track A

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

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

12:20 – 13:20

Session 6, Track A

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

13:20 – 14:10

The Core of Healthcare Data Governance: Data Standardization

Yuzhong Cha, OMAHA

Research & Development of Data Visualization System based on CDISC Standard

George Xiang, TrustCRO

Session 7, Track A

14:10 – 15:50

Informationization and AI analysis in Clinical Trial Data

Yonglong Zhuang, 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

Define SDTM before starting your study

Xiao Li, XClinical

Session 7, Track B

14:10 – 15:50

Beginner's approach to learning the CDISC standards and recommendations

Kuishou Yu, TrustCRO

Where we should begin with the Trial Design domains

Guang Huang, Shelly Jin, Sanofi

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

John Wang, C3C Vice Chair
16:20 – 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