2017 China Interchange Presentations

Thank you for attending the 2017 China Interchange in Beijing. You will find presentations from the conference below.

Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.

 

Session 1: Opening Plenary & Keynote

Opening Remarks

Dr. David Hardison, CDISC Board Chair

Opening Remarks

David R. Bobbitt, CDISC President and CEO

Keynote Presentation

CFDA/CDE

U.S. Regulatory Update

FDA Representative Invited

Japan Regulatory Update

PMDA Representative Invited

 

Session 2: The Past, Present and Future of CDISC Standards

CDISC Standards in 2017 and Forward

Rhonda Facile, CDISC VP, Standards Development

SHARE 2.0

Dr. Lauren Becnel, CDISC VP, Strategy and Innovation

CDASH and SDTM: Why Do We Need Both Standards?

Kit Howard, CDISC Director, Education

 

Session 3: Data Submission in China from the CFDA's Perspective

CFDA/CDE Presentation

CFDA/CDE Speaker Invited

CFDA/CDE Presentation

CFDA/CDE Speaker Invited

 

Session 4: Compliance and Regulatory Topics

 

Session 5: An Introduction to CDISC Standards

CDISC ODM Update and Implementation

Bryant Xiao, Mobile MD

Update on CDISC TA Standards

Ruiling Peng, C3C Vice-Chair, Improve-Quality

 

Session 7, Track A: Use Cases in Standards Application

 

Session 7, Track B: Process, Efficiencies and Tools

 

Session 8, Track A: Use Cases in Standards Application

 

Session 8, Track B: Process, Efficiencies and Tools

 

Session 9, Parts I & II: CDISC Standards for Therapeutic Areas