Again we are offering four (4) exciting seminars covering a variety of topics and taught by leading experts! Any of these seminars is sure to enhance your conference experience! Plan now to arrive in Shanghai early to take advantage of these affordable classes. There is an additional fee for taking a seminar. All seminars are half-day and the cost is 910 RMB/$130 USD each! You must register for the conference as an attendee in order to enroll in seminars. Class material will be provided.
Space is limited, so sign up early online when you register for the conference! Please carefully read the seminar rules and policies before you register AND keep a copy of your conference registration for your records!
All seminars are held in the conference hotel on Thursday July 6, 2017 from 8:30AM to 5:30PM. Two seminars are scheduled concurrently in the morning and two in the afternoon.
Seminar Registration starts at 7:30AM-9:30AM for morning seminars and 12:30PM-2:30PM for afternoon seminars.
Thursday, July 6, 2017
| Time | Course Title (click for description) | Instructor (click for bio) |
| 7:30AM-9:30AM | Morning Seminar Registration | |
| 8:30AM– 12:30PM | Seminar 1 - Bioequivalence study: Biometrics and quality management (生物等效研究中的数据管理统计和质量管理) (to be taught in Chinese) |
Dr. Wei Minji, Professor of Institute of Clinical Pharmacology, Peking University, Mr. Deng Yazhong, General Manager of Beijing Trust Medical Consulting Co. ltd |
| 8:30AM– 12:30PM | Seminar 2 – e-Submission Ready ADaM | James Wu of TigerMed-BDM Consulting, Inc., USA |
| 12:30PM-1:30PM | LUNCH BREAK | Lunch On Your Own |
| 12:30PM-2:30PM | Afternoon Seminar Registration | |
| 1:30PM-5:30PM | Seminar 3 – Utilizing Advanced SAS Macros to Quickly Perform Safety Assessments of Investigational Drug | Kriss Harris of SAS Specialists Limited, UK |
| 1:30PM-5:30PM | Seminar 4 - Data Visualizations in Clinical Research with Integration of SAS in Spotfire | Zhijun (Stanley) Wei of Novartis, China |
Instructor Biographies
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Kriss Harris worked at GlaxoSmithKline for almost 6 years from 2005 to 2011 as a Statistician supporting drug discovery. Whilst at GSK he developed an increasing passion for teaching and taught SAS Graphics and SAS Enterprise Guide to SAS Programmers, Statisticians and Scientists. Since then Kriss has moved on to become an independent Statistical Programmer and has consulted at Eli Lilly and Eisai. Currently Kriss is consulting at Eli Lilly supporting early phase Oncology, which involves creating advanced SAS Macros and SAS Graphics to investigate and report the safety of the compounds. Kriss has been an active participant at the SAS Global Forums and PharmaSUG Conferences and in 2010 was also awarded the title SAS Student Ambassador. Kriss holds an MSc in Statistics from the University of Sheffield, and is a SAS Certified Base Programmer, SAS Certified Advanced Programmer, SAS Certified Clinical Trials Programmer, and a SAS Certified Statistical Business Analyst. Kriss is currently learning Mandarin and is excited about using some of the Mandarin he has learned, at the PharmaSUG China conference in July 2017. |
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James Wu has more than 17 years of statistical programming experience in pharmaceutical industry and additional 10 years of R&D experience in data analysis and computer modeling. James managed several stat programming groups at Merck, Sanofi, MTDA and BDM. James also led global cross-site committees and working groups on the system development, standardization, SOP, guidelines, templates, and SAS macro library development, and e-submission preparation. 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. James holds Ph.D in environmental engineering from McMaster University in Canada, and MSc in Academic Science in China. Currently James is the vice-president, Global Business Operation at TIGERMED-BDM Consulting, Inc., and General Manager at Tiger-Xinzhe Medical Technology (Shanghai) Ltd., Inc. |
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Zhijun (Stanley) Wei is Group Head of Cardio-Metabolism Franchise in Statistical Reporting at Novartis Pharmaceutical. He is also currently undertaking a role in tools development in the Technology Standards and Processes group. Stanley graduated from School of Pharmacy, Fudan University in 2006, with a Master’s degree in pharmacology and has more than 10 years of industrial experience in data manipulation, reporting and analysis, including 6+ years of CDISC standards implementation with clinical trial data (SDTM, ADaM and Define.XML) and 4 years of analysis with real-world observational databases (including US claims database, UK GPRD, IMS database, etc.). Prior to joining Novartis, Stanley also worked in PPD and Medifacts International for about 4 years as a programming manager. Stanley is also one of the core and initial C3C (China CDISC Coordinating Committee) members, and has been responsible for the coordination of the CDISC China authorized trainer program, public training events, and is also the webmaster of the C3C official website for multiple years. In addition, he also coordinated and participated in the review process of the translated Chinese version of CDISC standards. |
| Dr. Wei Minji is the director of the Department of Pharmacokinetics at the Institute of Clinical Pharmacology, Peking University. He is an external advisory expert on PK for the CFDA New Drug Evaluation Center, and the on-site inspector of the CFDA Inspection Center. Professor Wei is the primary lecturer of INSTITUTE OF EXECUTIVE DEVELOPMENT in CFDA, focus on bioanalytic, he has been involved in more than 10 regulations development or revisions for new drug development. Professor Wei’s research areas include: biological sample analysis compliant with current regulations, PK, PK / PD modeling and simulations. Professor Wei Minji has accumulated a lot of experience in small molecule drug testing and research, and has a unique insight in this area. Mr. Deng Yazhong is the former senior director of clinical Data and reporting organization of Covance. He has been in the industry for 15 years, focusing on data management and biostatistical analysis organization. Mr. Deng is both a committee member of China Clinical Data Management working group (CDMC) and DIA Advisory Council of China (ACC). |
Course Descriptions
1. Bioequivalence study: Biometrics and quality management (生物等效研究中的数据管理统计和质量管理)
(to be taught in Chinese)
By Dr. Wei Minji, Professor of Institute of Clinical Pharmacology, Peking University
Mr. Deng Yazhong, General Manager of Beijing Trust Medical Consulting Co. ltd
Thursday, July 6, 2017, 8:30 AM - 12:30 PM
Bioequivalence evaluation mainly involves medical research and clinical research. The most important thing in clinical research is the bioequivalence study in vivo, that involves study design, determination of plasma concentrations, calculation of pharmacokinetic parameters, data management processes, bioequivalence analysis and statistical analysis of safety data. In the current bioequivalence studies, there are common mistakes such as flaws in study designs, inaccurate data collection, incorrect application of statistical analysis methods, etc.. More over, there is a challenge on how to proceed to the next step after the pilot study, or in the case of biological unequivalence.
In order to present a clear understanding of the methodology, study design and statistical analysis of bioequivalence studies, two experts of PK/BE and biostatistics have been invited to this seminar to provide detailed training of the key techniques as well as some most recent case studies.
- Study design of PK/BE studies
- The standard procedure of Blood sample handling, testing and reporting
- Data management in BE study
- Statistical approaches to establishing bioequivalence
- Design and statistical analysis for product with high variance
- Case studies: decision-making after Pilot BE, failed BE analysis, and BE data mining
2. e-Submission Ready ADaM
By James Wu, TigerMed-BDM Consulting, Inc., USA
Thursday, July 6, 2017, 8:30 AM - 12:30 PM
Covers all aspects of Analysis Data Model (ADaM) from the development of the datasets to the e-submission package preparation related to analysis datasets:
- Data Flow and CDISC
- ADaM model and implementation guide
- The Subject-Level Analysis Dataset (ADSL)
- The Basic Data Structure (BDS)
- ADaM for the individual studies
- ADaM for the integgrated analysis for ISS/ISE
- OpenCDISC validation and reporting
- Analysis Data Reviewer’s Guide
- Define.xml and define.pdf
- eCTD Module 5 structure for ADaM
Many examples will be given to help attendees learn the basic concepts and the approaches to handling various challenges.
3. Utilizing Advanced SAS Macros to Quickly Perform Safety Assessments of Investigational Drug
By Kriss Harris, SAS Specialists Limited, UK
Thursday, July 6, 2017, 1:30 PM – 5:30 PM
Utilizing advanced SAS macros can help you to create more efficient and reusable programs, and therefore help your organisation to save time.
This 1/2 day seminar will guide you through the necessary SAS macro statements and functions, and code, which are needed in order to create advanced macros which are extremely useful in assessing the safety profile of the drug. You will learn how to create macros which can:
- Read in tracking sheets
- Automatically run all your programs
- Automatically know the location of your SAS program
- Create the demography summaries
- Create the treatment adverse event rates
- Help to calculate laboratory CTC grades
- Create Kaplan Meier Figures
Intended Audience: SAS Programmers who have basic knowledge of how to create SAS macros.
4. Data Visualizations in Clinical Research with Integration of SAS in Spotfire
By Zhijun (Stanley) Wei, Novartis, China
Thursday, July 6, 2017, 1:30 PM - 5:30 PM
Spotfire is one of the most popular and powerful visualization tools and has been widely used in multiple aspects of the pharmaceutical industry and clinical research, including but not limited to KPI (key performance indicator) management, RBM (risk-based management), subject recruitment and site monitoring, data review, miscellaneous metrics and standard reports, etc.
The main objective of this seminar will be to introduce you to fundamental functions and usage of Spotfire and help you gain the necessary knowledge to build your own interactive visualizations and reports from diversified data sources. Key learning points include source data import and transformation, many kinds of interactive chart and table development, advanced usages of data markings and filters with property controls, integration of data functions with SAS scripts, etc. Some examples used in clinical research will also be demonstrated.
Intended Audience: Those who are new to Spotfire and would like to use Spotfire for interactive visualization development. Those who already have some basic knowledge of Spotfire and would like to improve and learn some advanced skills will also benefit from this seminar.
SEMINAR REGISTRATION, ATTENDANCE AND CANCELLATION POLICY
Please read carefully the following seminar rules before you register AND keep a copy of your conference registration form for your records!!
- You must register for the conference as an attendee in order to attend any seminar.
- You must register for a seminar via the online PharmaSUG China conference registration.
- If you have paid the full registration and seminar fee, you may cancel a seminar on or before May 15, 2017 and receive a full refund minus a $25 USD/175 RMB administration fee for each cancelled seminar.
- You may NOT swap one seminar for another after May 15, 2017.
- There will be NO REFUNDS on or after May 15, 2017. However, if you are unable to attend, the seminar material will be provided to you (via email) without additional charges.
- Seminar registration is scheduled from 7:30 AM - 9:30 AM for the morning seminars and 12:30 PM - 2:30 PM for the afternoon seminars. At the Registration, each attendee is provided with a special badge which is specific to each seminar. This seminar badge is entry to your seminar that you signed up. Please wear your specific seminar badge in each seminar that you attend.
- You can pay and take two seminars concurrently, i.e., attend one seminar and take the class material from another seminar.
- Should a seminar be cancelled at any time for any reason, the sole liability of PharmaSUG China and the instructor is a full refund of the seminar fee, and they are NOT liable for any special or consequential damages arising from the cancellation of the seminar.
- On-site registration will be permitted based on space and availability, and payable by cash (no personal checks) or by major credit card (MC, VISA, Discover, AMEX). That is, the onsite payment cannot be made via money transfer. However, seminar materials may not be available on-site but will be provided via emails later to paid attendees.
For questions about the above seminar policy and availability, please contact Margaret Hung at This email address is being protected from spambots. You need JavaScript enabled to view it..