Shanghai, China



Focus on ADaM and TLF Standardisation


The second PhUSE Single Day Event in China took place in the Parkyard Hotel, Shanghai on November 28th, 2014. This was another very successful and well received PhUSE event. It attracted about 95 attendees from various pharmaceutical companies, CROs, Vendors and Universities. The theme of this event focused on CDISC ADaM standards and TLFs standardisations. The agenda covered a good variety of topics, including high-level presentations about what is going on in the industry with regard to ADaM standards and guidance and also a hands-on demonstration on ADaM creation and real-life tools for TLF standardisation and visualisation.


Through the event we now have many more people who know about PhUSE and the Single Day Events in China. The audience was fully engaged during the day, and feedbacks from attendees were extremely positive.  We believe attendees have grasped up-to-date ADaM standards and understand how it was implemented in different organisations and help them to streamline the TLFs standardisations, speed up the execution of clinical trial data analysis and reporting process with high quality. Besides, all the attendees have enjoyed and appreciated the networking session. This event will be a successful and unforgettable experience for all.



Welcome and Introduction - Stanley Wei, Novartis

ADaM Standards Overview and Future Outlook - Zibao Zhang, PPD

Introduction of Analysis Data Reviewer's Guide from PhUSE - John Wang, J&J

Thinking Vertically in ADaM Programming for Occurrence Data - Penny Pang, Novartis

Introduction of EXACT - a Tool for ADaM Generation, Liguo Cheng, WuXiPRA

ADaM Creation Process and Template - Ke Xin, FMD K&L

Introduction of ArtZ - Standard TLF Macros and Output Validation, Wanqing Li , PPD

Visualisation of TLF Standards for Clinical Trial Data Review,  Dr. Bao Wenjun ,SAS JMP

Standardisation and Visualisation of TLFs in Safety Review, Dong (Thomas) Guo, Eli Lilly

How to Use SAS to Help Enhance Quality in IDB Studies - Pamela Chen, MacroStat

An SAS-based Tool Introduction for TLF Program Management, Billy Xin, J&J

A Metadata-Driven Approach to Streamline AE Groupings, David Wang, Roche

Modular Macros to Facilitate TLF Programming, Zhenglong Tian, Parexel

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