Shanghai, China

Friday 6th November 2020

 

Due to the latest developments of COVID-19, the PHUSE Shanghai SDE will be a
virtual event and open to all.

Register now

 

Theme:

Embracing Evolution: Clinical Data Science in the 2020s

Description:

Year 2020 is an extraordinary year, especially for the pharmaceutical industry, with the coexistence of the opportunities and challenges coming in the next decade. It is a year with both expected and unexpected change. As the NMPA published the new guidelines and provisions, and with the rapid development and application of new technologies, such as R and Python, more innovative actions should be taking place with the newly updated submission environment and standards in China.
 
In addition, the global pandemic of COVID-19, which highly influences our way of life, also brings obstacles in clinical trials. All these challenges will reshape our way of working.
 
During this SDE, we'll discuss how these emerging trends are changing our work, and what we can do to embrace the changes.

 

PHUSE App:

NOW LIVE!

Utilise the PHUSE App to connect with other attendees, view the speaker profiles and learn more about the event sponsors.

Sponsored by:

 

Agenda:

Time (CST) Presentation Speaker(s)
08:45–09:00 Attendees join webinar
09:00–09:10 Welcome and PHUSE Updates

Xin Wang (王昕),
ClinChoice
Yu (Penny) Pang (庞裕),
Novartis

09:10–09:40 New Pinnacle 21 Validator Supports NMPA Submissions Max Kanevsky,
Pinnacle 21
09:40–10:10

Bilingual e-Submission Convention for Regulatory Agencies

Qin Meng (孟钦),
dMED

10:10–10:30 Networking Break
10:30–11:00

Tracecart: Trace Back Clinical Data from Analysis to Source Automatically and Efficiently

Haiqiang Luo (罗海强),
Hengrui

11:00–11:30

CRF-driven SDTM Automation

Chunpeng Zhao (赵春鹏),
BeiGene

11:30–13:00 Lunch Break
13:00–13:30

Natural Language Processing (NLP) in SAS and Related Application Exploratory

Lee Wan (万里行),
Tigermed-MacroStat

13:30–14:00

How to Handle Re-screening Data in SDTM and ADaM?

Chao Zhai (翟超),
Novartis

14:00–14:30 Networking Break
14:30–15:00

Case Report: Reduce the Impact of COVID-19 in China Clinical Trials

Min Chen (陈敏),
Lilly

15:00–15:30

SDTM Mapping Under the COVID-19 Pandemic – Rapidly Developed Standards

Nancy Ni (倪勤),
Everest

15:30–16:00

COVID-19 Related Protocol Deviation, and Reporting in CSR Outputs

Zhang Zhizhuo (张智卓),
Novartis

16:00–16:10 Closing Remarks Xin Wang (王昕),
ClinChoice
Yu (Penny) Pang (庞裕),
Novartis

 

SDE Chairs:

Xin Wang, ClinChoice

Yu (Penny) Pang, Novartis

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

 

Sponsors:

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

        

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