Beijing, China

17th May 2019

 

Registration has now closed for this event, please contact the Chairs for further information. Contact details can be found further down on this page.

 

Theme:

Interaction with Data – Regulatory Requirements and Automation Applications

 

Description:

The 10th PhUSE SDE China focusses on how we interact with data effectively and efficiently, not only from a regulatory requirements perspective but also in terms of innovative automation applications.

Data science has never been hotter than it is today, and the choice of ideas, methodologies, technologies and solutions from data collection, integration, visualisation and data mining is greater than ever, but we still have a lot of questions: how do we identify or even adapt the appropriate methodologies or technologies in clinical trial operations in each stage of the clinical data flow? Do they align with emerging regulatory requirements? How do we implement them and what is the cost and added value in the immediate, middle and long term?

To answer these questions, we look forward to welcoming presenters who can share their experiences, practical guidance and lessons learned about data science in the pharmaceutical industry.

Attendees will understand and engage in talks discussing successful implementation of emerging data technologies, both within industry and from a regulatory requirements perspective, and how data science will impact on the future of different roles within drug development.

 

Location:

MSD R&D China

2F, Building 21 Rongda Road, Wangjing R&D Base,

Zhongguancun Electronic Zone West Zone,

Chaoyang District

Beijing 100012, China

 

Agenda:

Time Presententation Speaker
08:30–09:00 Registration
09:00–09:05 Welcome Haiqiang Luo,
PPD
09:05–09:15 Opening Remarks Jie Ding,
MSD
09:15–09:45 eCTD Implementation in China – Technology, Processes, Standards and Organization Eason Yang,
Novartis
09:45–10:15 A Glance at Quality Tolerance Limits (QTLs) Lu Zhang,
PPD
10:15–10.35 Coffee Break
10:35–11:05 The Role of Biostatisticians in Detecting Fraud Sean Chang,
PAREXEL
11:05–11:35 iClinicalTrial Design and Operation Based on Intelligent Clinical Trials Zhi He,
HLT Pharma
11:35–12:05 One-stop Solution for Bioequivalence Analysis Jiameng Yuan,
HIGHTHINK MED
12:05–13:30 Lunch Break
13:30–14:00 Strategic Thinking for Program Automation Leo Li,
Innovent Biologics
14:00–14:30 Statistical Analysis Plan (SAP) Automation Using Python Aide Zhou,
BeiGene
14:30–15:00 Transformation of the Statistical Analysis and Reporting Process Through Intelligent Automation Dong Fang,
Pfizer
15:00–15:20 Coffee Break
15:20–15:50 Machine Translation in Clinical Trial Development Camus Liu,
Sanofi
15:50–16:20 Automatically Generating Statistical Analysis Reports for Bioquivalence Studies Jianfeng Ye,
Taimei Technology
16:20–16:50 Panel Discussion

All speakers, along with the PhUSE China Committee will participate

16:50–17:00 Closing Remarks

Eric Li,
BeiGene

 

SDE Chairs:

Haiqiang Luo, PPD

Jinling Li, BeiGene

If you have any questions, or require any information, please contact one of the SDE Chairs.

 

Sponsors:

If you are interested in sponsoring this event, click here.

 

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There are two easy ways to join PhUSE:

1. Register online.

2. Contact membership@phuse.eu for group membership applications or for invoicing arrangements.

   

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