Again, we are offering Four half-day seminars, two in the morning and two in the afternoon on the day before the conference on Thursday August 29, 2019. The cost is USD $130/ Yuan 910 which is an additional fee from registration

Thursday morning – 8:30 am -12:30 pm

1. Advanced Topics on ADaM Creation for e-Submission By James Wu

This seminar will cover all aspects of Analysis Data Model (ADaM) from the development of the datasets to the e-submission package preparation related to analysis datasets: 1) Data Flow and CDISC; 2) ADaM model and implementation guide; 3) The Subject-Level Analysis Dataset (ADSL); 4) The Basic Data Structure (BDS); 5) Other ADaM Datasets ; 6) OpenCDISC validation and reporting; 7) Analysis Data Reviewer’s Guide; 8) Define.xml and define.pdf; 9) eCTD Module 5 structure for ADaM; 10) Business Decision and Risk Analysis for Legacy Study Submission;

A lot of examples will be given to help attenders to learn the advanced concepts and the approaches to handle the challenge data scenarios.

Intended Audience: Audiences from all industries with different job roles will be benefit by taking this seminar.

2. Tutorials of using Python Pandas , Dash and Flask to build visual analytics of clinical data By Haiping Yu

Python is a multi-purpose and open source programming language which has become very popular in data science due to its active community and rich libraries. Pandas is one of the most popular Python package for data science, it offers powerful, expressive and flexible data structures that make data manipulation and analysis easy. Dash is Python framework built on top of Flask, Plotly.js and React. It is a very powerful tool to quickly building web-based visualized analytical tools without having a lot of knowledge of web technologies. This tutorial is prepared for those who have experience of any programming language and are new to Python Pandas and Dash . In this tutorial, we will learn how to use Pandas to prepare the datasets from clinical trial, then use Dash to build app rendering interactive charts to support safety and efficacy review. After completing this tutorial, you will understand how productive it is to build a data visualization and business intelligence platform by using pure Python.

Thursday afternoon – 01:30 - 05:30 pm

3. An Introduction to Tidyverse, Shiny, and R Markdown with Applications in Drug Development By John Wang

This is an overview of Tidyverse, Shiny, and R Markdown for the R user community at PharmaSUG China. This is a great opportunity to learn and get inspired about new capabilities for creating compelling analyses with applications in drug development. No prior knowledge of R, RStudio or Shiny is needed. This short course will provide an introduction of flexible and powerful tools for data wrangling, statistical analysis, reproducible research and interactive visualizations. The hands-on course will include an overview of how to do basic data wrangling, build Shiny apps, generate R Markdown documents and visualizations for R. CDISC formatted datasets examples will be reviewed and generated for each topic.

4. Mastering the define.xml By Angelo Tinazzi

define.xml is a required piece of all electronic data submissions that include SDTM and ADaM packages for both FDA and PMDA. It is a key instrument for the reviewer to understand how you organized the data you collected and how you have analyzed them. The good quality of the define.xml is your “business card” for the agency.

This seminar, after briefly introducing some basic xml concepts, will discuss the main define.xml metadata and their key attributes, how they relate to each other and how to make sure your metadata are consistent with the data and between SDTM and ADaM. Examples of good metadata to describe complex situations will be discussed as well as common misuse. The seminar will also introduce the use of stylesheets to make define.xml readable and the main available free and commercial tools available in the market.

Pre-requisites: Understanding of CDISC SDTM and ADaM and their metadata


James Wu has 20+ years of statistical programming experience in pharmaceutical industry. James managed several stat programming groups at Merck, Sanofi, MTDA and BDM. James served PharmaSUG as EC member, 2010 PharmaSUG conference chair, PharmaSUG China 2013 conference chair, and Philadelphia University over the past 10+ years as an adjunct instructor for the SAS Programming Certification Program.

Haiping Yu has 14+ years of experiences in new drug R&D industry, especially in software development in drug discovery and clinical research. He joined dMed in 2017, he and his team developed many Python programs for automation, web services & applications, data Analysis and task queue, to fuel innovation at every level of clinical data management. Before he joined dMed, he was Manager, Technical Process Lead of Clinical Data Management at Pfizer China R&D Center since 2009, in this position, he was responsible for clinical trial data standards implementation and software technology innovation, wrote many programs using VBA and VB.NET. Prior to that, he was Research assistant at Chinese National Center of Drug Screening, Chinese Academy of Sciences. During this time he developed web applications for management of high-throughput compound screening and lab materials, in order to achieve this, he started to learning PHP and MySQL and soon became an expert. Haiping is the Associate Director, Techinical Operation Lead of Clinical Data Management at dMed Biopharmaceutical Co., Ltd.

John Wang is Associate Director, Statistical Analysis, at dMed Biopharmaceutical Co., Ltd. He has 10+ years extensive statistical analysis experience in all phases of clinical trials, is familiar with different kinds of programming languages and system tools in clinical research. Before he joined dMed, he was Manager of SAS Programming at Johnson & Johnson China since 2009. Prior to that, he was associate manager of SAS programming for four years at Global Research Services, LLC. He is Vice Chair and team lead for the SDTM group in C3C (China CDISC Coordinating Committee). He has very extensive experience using CDISC fundamental data standards such as CDASH, SDTM, ADaM, Controlled Terminology and define.xml. He became a CDISC authorized SDTM Instructor in early 2016.

Angelo Tinazzi is a Senior Director at Cytel leading the Standards, Systems, CDISC Consulting group. With more than 20 years of experience with different roles in Academic Organizations, CROs and Pharmaceutical Industries, in Italy, Switzerland and UK, Angelo is also member of the European CDISC Committee where he also manages the Italian speaking CDISC UN. He is a CDISC ADaM Authorized Instructors as well stream chair for CDISC-EU Interchange and PhUSE-EU Connect.