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 Beijing 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 780 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 September 8, 2016 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, September 8, 2016

Time Course Title (click for description) Instructor (click for bio)
7:30AM-9:30AM – Grand Ballroom Foyer Morning Seminar Registration
8:30AM– 12:30PM Grand Ballroom D1 Seminar 1 – Clinical Graphs Using SG Procedures Sanjay Matange of SAS Institute, USA
8:30AM– 12:30PM Grand Ballroom D2 Seminar 2 – Some Techniques for Exchanging Data and Analytical Results between SAS® and Microsoft Excel Vince DelGobbo of SAS Institute, USA
12:30PM-1:30PM LUNCH BREAK Lunch On Your Own
12:30PM-2:30PM – Grand Ballroom Foyer Afternoon Seminar Registration
1:30PM-5:30PM Grand Ballroom D1 Seminar 3 - Advanced Clinical Graphs Using GTL Sanjay Matange of SAS Institute, USA
1:30PM-5:30PM Grand Ballroom D2 Seminar 4 - e-Submission Package Preparation Cindy Song of Sanofi, China/USA
James Wu of TigerMed-BDM Consulting, USA

**** Want to win a SAS book? Your will be awarded a SAS book if you are the first person to sign up and pay (i.e., registered and paid) for a specific seminar by May 31, 2016! There is a winner for each of the four classes.

 

Instructor Biographies


Vince DelGobbo is a Senior Software Developer in the Metadata and Execution Services group at SAS Institute. This group's responsibilities include the SAS/IntrNet Application Dispatcher and SAS Stored Processes. He is involved in the development of new Web- and server-based technologies, bringing 3rd-party metadata into SAS, and integrating SAS output with Microsoft Office. He was also involved in the early development of the ExcelXP ODS tagset. Vince has been a SAS Software user since 1982, and joined SAS in 1992.


Sanjay Matange is R & D Director in the Data Visualization Division at SAS, responsible for the development and support of ODS Graphics. This includes the Graph Template Language (GTL), Statistical Graphics (SG) procedures, ODS Graphics Designer and other related graphics applications. Sanjay has been with SAS for over 20 years, co-author of two patents, author of two SAS Press books and author of Graphica.


Cindy Song is Director, programming group head at the biostatistics and programming department at Sanofi, a leading global pharmaceutical company. She has been with the company for more than 11 years with 10+ years at the company’s Bridgewater, New Jersey site. Currently she is on a short-term assignment working at the company’s Beijing, China office.

Prior to Sanofi, Cindy was a manager of a statistical programming group at Merck’s clinical biostatistics department in Rahway, New Jersey, and had worked there for more than 10 years. Cindy co-chaired PharmaSUG 2007 and the first PharmaSUG China in 2012, and is a member of the PharmaSUG executive committee. During her 21 years of clinical programming experience, Cindy has developed a broad interest and in-depth knowledge in programming technologies and processes, as well as clinical development operations and regulatory standards.


James Wu has more than 16 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. Current James is the vice-president, Global Business Operation at TIGERMED-BDM Consulting, Inc., and General Manager at Tiger-Xinzhe Medical Technology (Shanghai) Ltd., Inc.

Course Descriptions

1. Clinical Graphs Using SG Procedures
By Sanjay Matange, SAS Institute Inc.
Thursday, September 8, 2016, 1:30 PM - 5:30 PM

Graphs used in the Health and Life Sciences domain and Clinical Research have special requirements to display data in a clear and concise manner including raw data and derived statistics. Data needs to be displayed by treatment, visit and other classifiers along with related information such as Subjects at Risk aligned with the horizontal or vertical axis.

This ½ day presentation will introduce you to the key concepts of the SGPLOT and SGPANEL procedures including the layering of plot statements to create the graph you need. We will review the process and features by creating graphs commonly used in the Pharmaceutical industry. These include Mean Change in QTc by Visit, Distribution of ASAT by Time and Treatment, Survival Plot, Forest Plots, Adverse Event Timeline, Waterfall Chart for Change in Tumor Size, Distribution of Maximum LFT Values by Treatment, Swimmer Plot, Panel of LFT Shifts by Treatment and Immunology Profile..

Audience: Graph programmers required: Basic SAS programming skills. .


2. Some Techniques for Exchanging Data and Analytical Results between SAS® and Microsoft Excel
By Vince DelGobbo of SAS Institute
Thursday, September 8, 2016, 8:30 AM - 12:30 PM

This course is designed to teach several techniques for integrating SAS® data and analytical results with Microsoft Excel. Attendees learn how to import Excel data into SAS using different methods, such as the IMPORT procedure, the SAS Data Step, and SAS Enterprise Guide. Exporting data and analytical results from SAS to Excel is performed using the EXPORT procedure, the SAS Data Step, SAS Enterprise Guide, the SAS Output Delivery System (ODS) and other tools. The material is appropriate for all skill levels, and the techniques work with various versions of SAS software. Adequate time provided to answer attendee questions.


3. Advanced Clinical Graphs Using GTL.
By Sanjay Matange, SAS Institute Inc.
Thursday, September 8, 2016, 8:30 AM - 12:30 PM

Graphs used in the Health and Life Sciences domain and Clinical Research often require the display of data in multi cell layouts. The data are displayed by treatment, visit and other classifiers along with related information aligned with the horizontal or vertical axis.

This ½ day presentation will cover the features of the Graph Template Language (GTL) for creation of advanced clinical graphs. We will cover different layout containers and plot statements, and how these can be combined to create graphs. We will cover advanced topics such as use of Dynamics and Expressions to create graphs commonly used in the Pharmaceutical industry. These include Distribution of ASAT by Time and Treatment, Most Frequent On-Therapy Adverse Events Sorted by Relative Risk, Forest Plot by Subgroups, Lab Values Matrix, EPI curve graph, Survival Plot and Gene and Drug correlations Heat Map.

Audience: Advanced Graph programmers required: Moderate to advanced SAS programming skills.


4. e-Submission Package Preparation
By Cindy Song, Sanofi, China/U.S.; James Wu, TigerMed-BDM Consulting, Inc.
Thursday, September 8, 2016, 1:30 PM - 5:30 PM

How does a FDA e-submission package look like? What are included in the submission? And what do I need to do to prepare for a submission package? If you ever wonder about these questions, this seminar is for you. As more and more requirements are added to the e-submission, it is critical for a sponsor to have a thorough knowledge of these requirements.

We will discuss the following topics to guide you through the submission preparation:

  • eCTD Module 5
  • CRF annotation
  • SAS Transport Files
  • Define.xml and define.PDF
  • Study Data Reviewer's Guide
  • Analysis Data Reviewer's Guide
  • Tips for Do’s and Don’ts during Preparation

This seminar will explain the content and structure of a typical e-submission package, and will give examples and step-by-step processes on how to prepare each component of the package.

Audience: Any SAS programmers who would like to gain knowledge and skills on e-submission preparation.

*The seminar is taught in English; however, the audience is welcome to raise their questions in both English and Mandarin. Both instructors can speak Mandarin fluently.


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!!

  1. You must register for the conference as an attendee in order to attend any seminar.
  2. You must register for a seminar via the online PharmaSUG China conference registration.
  3. If you have paid the full registration and seminar fee, you may cancel a seminar on or before July 4, 2016 and receive a full refund minus a $25 USD/150 RMB administration fee for each cancelled seminar.
  4. You may NOT swap one seminar for another after July 4, 2016.
  5. There will be NO REFUNDS on or after July 4, 2016. However, if you are unable to attend, the seminar material will be provided to you (via email) without additional charges.
  6. 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.
  7. You can pay and take two seminars concurrently, i.e., attend one seminar and take the class material from another seminar.
  8. 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.
  9. 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..