Beijing, China

17th May 2019

Interaction with Data – Regulatory Requirements and Automation Applications



Themed “Interaction with Data – Regulatory Requirements and Automation Applications”, the 2019 PHUSE Beijing Single Day Event was held on May 17th at the MSD China R&D Center. The event witnessed over 90 participants from academia, global and local pharmaceuticals, as well as CROs.
We had interesting discussions throughout the day, focussing on data science and regulatory requirements, 10 presentations which covered the progress of eCTD implementation in China, risk-based monitoring implementation strategy, and innovative tools based on machine learning and intelligent automation. The event rounded off with a highly engaging panel session.
It was a great day, with a very positive and collaborative atmosphere and strong content. The SDE Chairs would like to thank the speakers, panellists and the moderator for their time and efforts, the sponsors for making the day possible, and all the attendees for making the event enjoyable and successful.



eCTD Implementation in China – Technology, Processes, Standards and Organization – Eason Yang, Novartis

A Glance at Quality Tolerance Limits (QTLs) – Lu Zhang, PPD

The Role of Biostatisticians in Detecting Fraud – Sean Chang, PAREXEL

iClinicalTrial Design and Operation Based on Intelligent Clinical Trials – Zhi He, HLT Pharma

One-stop Solution for Bioequivalence Analysis – Jiameng Yuan, HIGHTHINK MED

Strategic Thinking for Program Automation – Leo Li, Innovent Biologics

Statistical Analysis Plan (SAP) Automation Using Python – Aide Zhou, BeiGene

Transformation of the Statistical Analysis and Reporting Process Through Intelligent Automation – Dong Fang, Pfizer

Machine Translation in Clinical Trial Development – Camus Liu, Sanofi

Automatically Generating Statistical Analysis Reports for Bioquivalence Studies – Jianfeng Ye, Taimei Technology


View the event brochure.


SDE Chairs:

Haiqiang Luo, PPD

Jinling Li, BeiGene




Photos of the Day:









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