Seminars for website by ashrafp


									                                Pre/Post-Conference Seminars
                                A Total of 11 Seminars covering a variety of topics!
Again we are offering a variety of affordable conference seminars! This year there are more intermediate and
advanced seminars covering a wide range of subjects, from SAS-related topics to XML, from program validation to
CDISC standards. There will be four seminars on Saturday, five on Sunday and two on Wednesday. All are ½ day
and the tuition is $95 each. The seminar fee is in addition to the conference registration fee. Each seminar attendee
will receive course material and a completion certificate. Space is limited, so sign up early using the conference
registration form in this booklet or online as you register for the conference. Please read the seminar description
before you sign up and make a copy of the conference registration form for your records.
Sign Up, Attendance and Cancellation Policy
1. You must register for the conference in order to attend any of the seminars.
2. You must sign up to take any of the seminars via PharmaSUG 2004 conference registration either by form, fax or online.
3. If you cannot attend a seminar, you can ask another conference attendee to take your place as long as you notify the Conference
4. Registrar (Susan Fehrer) and the Seminar Coordinators (Margaret Hung and Sandra Minjoe) in advance.
5. You can cancel a seminar prior to April 16, 2004 with a full refund minus a $25 administration fee.
6. Prior to April 16, 2004, you can switch to another seminar; however, this ―switch‖ is considered a change in conference registration
   and therefore there will be a charge of $25. (Refer to Conference Registration. policy)
7. After April 16, 2004, you CAN NOT switch seminars; however, you can add a new seminar if there is still availability.
8. No refunds will be given after April 16, 2004. However, the seminar material can be mailed to you without charge.
9. Onsite registration is permitted based on availability.

For questions about the seminar policy above, availability, and/or sign up confirmation, please contact Margaret
Hung at or (919) 483-1345 or Sandra Minjoe at or (650) 225-4733.

Seminar Schedule
 7:30AM - 8:00AM                         Morning Registration
 8:00AM - 12:00PM                        Intermediate ODS: Formatting ODS Output: Part I (Greg Barnes
                                         Testing and Validating SAS Programs in a FDA Regulated
                                         Environment (Neil Howard)
 12:00AM -1:00PM                         LUNCH on your own
 12:30PM                                 Afternoon Registration
 1:00PM – 5:00PM                         Advanced ODS: Understanding ODS Objects: Part II (Greg
                                         Barnes Nelson)
                                         SAS Programming for the Pharmaceutical Industry (Carol
                                         Matthews and Brian Shilling)
 SUNDAY-May 23
 7:30AM - 8:00AM                         Morning Registration
 8:00AM - 12:00PM                        Intermediate and Advanced Topics of the SAS Macro Language:
                                         Moving Beyond the Basics (Art Carpenter)
                                         Analysis Data Sets in FDA Electronic Submissions: Concepts
                                         and Principles (David H. Christiansen)
                                         Get Productive with Proc SQL: The Basics and Beyond (Justina
                                         Flavin and Richard Severino)
 12:00PM - 1:00PM                        LUNCH on your own
 12:30PM                                 Afternoon Registration
 1:00PM - 5:00PM                         Be More Productive with Proc SQL: Advanced Techniques
                                         (Justina Flavin and Richard Severino)
                                         Building a Dynamic Application Using the SAS Macro Language
                                         (Art Carpenter)
 12:45PM                                 Afternoon Registration
 1:00PM - 5:00PM                         Accurate Manipulation of Clinical Trial Data (Tricks, Traps, and
                                         Techniques) (Malachy [Mal] J. Foley)
                                         Introduction to XML for Data Exchange Between SAS and Other
                                         Platforms (Miriam Cisternas and Ricardo Cisternas)

1. Intermediate ODS: Formatting ODS Output: Part I
Instructor:                Greg Barnes Nelson
Affiliation:               ThotWaveTechnologies, LLC

As President and CEO of ThotWave Technologies, Mr. Barnes Nelson leads software development activities and
oversees the design, testing, and implementation of application development services. Mr. Barnes Nelson joined
ThotWave with over 19 years of experience in market research, database marketing, systems development and
project management. Currently, Greg is responsible for developing ThotWave‘s service offerings for reporting and
analysis applications in the pharmaceutical and biotechnology industries.

Pre-requisite:             Exposure to SAS and using ODS for generating HTML and/or RFG Output
Intended audience:         For SAS programmers wishing to understand how ODS can be used for more than just
                           outputting standard SAS listing files to HTML, PDF or RTF. Experience with a
                           programming language is essential. Some exposure to object oriented concepts is a plus.
Course material:           Participants will be provided with a course handout, which will include all of the
                           presentation materials, as well as a CD-ROM with all of the examples and tools used in
                           the course.

Course description and outline:
ODS – or the Output Delivery System – was a major milestone in the development of SAS. With ODS, we now
have the ability to programmatically control the content, structure and format of how SAS renders content from any
Procedure and Data Step. Most uses of ODS have centered on its ability to take structured output from SAS –
normally thought of as the SAS listing – and redirect it to other formats such as HTML, PDF, and RTF. This course
is designed for SAS programmers who want to understand not only the fundamentals, but also expand on ODS‘
importance, uses, strengths and learn how to exploit ODS for managing complex content.

In the first part, we will lay the groundwork for ODS by summarizing the ways that ODS can be used to generate
output, what options are available as output targets and understand the limitations of each. Next, by building on your
existing knowledge of ODS, we will write some practical programs that give us control over appearance and style.
We will use our knowledge of Proc Report, Proc Print and Proc Tabulate to produce heavily customized reports. In
addition to understanding STYLE= syntax and STYLE templates, we will learn about using TABLE TEMPLATES
with procedures and the DATA step. Finally, we will introduce students to the concepts of ODS MARKUP for
creating tagsets used in HTML and XML document generation.

This course is not designed as a hands-on course, but examples will be provided for hands-on experience at home.
Special attention will be made to making this a thought-provoking seminar where participants will learn how to start
thinking in objects and apply their skills in developing SAS and ODS applications.


2. Testing and Validating SAS Programs in a FDA Regulated Environment
Instructor:                Neil Howard
Affiliation:               i3 Data Services

Neil Howard is Manager of Statistical Programming at i3 Data Services in Basking Ridge, NJ; she was with Pfizer
previously. A SAS user for more than twenty years, Neil has been an invited speaker since 1983 on such topics as:
efficiency techniques, advanced DATA step processing, testing, graphics, ‗effective presentations‘, and
interviewing/hiring SAS programmers. She was a contract instructor for SAS Institute for seven years, teaching
fundamentals, programming, macro, report writing, graphics and the annotate facility. A member of the SUGI
Executive Committee since 1993, she chaired SUGI 20 in Orlando. She is academic chair for SESUG ‘04 in
Pre-requisite:              Knowledge of Base SAS DATA step programming
Intended audience:          Beginning through advanced clinical SAS programmers, and statisticians who program
Course material:            Binder with copies of slides and worksheets

Course description:
This seminar will focus of the five Ws of testing and validating SAS programs, particularly in the context of an FDA
regulated environment, with special emphasis on the HOW with SAS tips and techniques:
        WHY: examination of FDA regulations and guidances; exploration of reviewers‘ expectations (processes
         and accountability); implications of audits; and discussion of client requirements and specifications
        WHAT: interpretation of the guidances; definition of the terms testing, debugging, verification and
         validation; and discussion of the types of things that must be validated
        WHO: accountability in pharmaceutical companies and CROs
        WHEN: planning and timing of testing and validation
        WHERE: some documentation specifics and tips
        HOW: SAS and programming tips and techniques (for programmers and statisticians) for debugging,
         testing, and validation of production and ad hoc code for tables, listings, figures and graphs; syntax, logic,
         requirements checking; error handling

The SAS system is easy to use and the learning curve to productivity is relatively short. But SAS is easy to abuse.
Indisputable facts remain: data is seldom clean, logic is too often faulty, and fingers walk clumsily over keyboards.
Condition codes are not an accurate indicator of successful programs.
Since as much as 80% of a programmer's time is invested in testing and validation, it's important to focus on tools
that facilitate correction of different types of errors in SAS programs. The workshop focuses on a variety of SAS
features, tips, techniques, tricks, and system tools that can become part of your routine testing methodology
consistent with 21 CFR Part 11 and other FDA guidances.


3. Advanced ODS: Understanding ODS Objects: Part II
Instructor:                 Greg Barnes Nelson
Pre-requisite:              Exposure to SAS and using ODS for generating HTML and/or RTF Output
Intended audience:          This course is designed for SAS programmers wishing to understand how ODS can be
                            used for more than just outputting standard SAS listing files to HTML, PDF or RTF.
                            Experience with a programming language is essential. Some exposure to object oriented
                            concepts is a plus.
Course material:            Participants will be provided with a course handout, which will include all of the
                            presentation materials, as well as a CD-ROM with all of the examples and tools used in
                            the course.

Course description:
This is the second of a two-part course in ODS for SAS Programmers. In this section, participants will apply what
they learned about the ODS and stylizing output to developing complex reports using ODS objects. Here,
participants will learn the ODS and how it relates to OO programming and the Object Model by exploring the ODS
objects that are available to us as programmers. Here, we will develop a series of reusable programs that can be
used to access metadata and output from procedures to create specifically designed reports that combine text, tables
and graphics. By using ODS LAYOUT and ODS GRAPHICS, we will focus on how customized reporting can
easily be accomplished. In addition, we will explore output objects that are not normally available as part of the
standard SAS listing or output datasets provided for by the PROCS. Finally, we will provide several case studies in
taking output that was created in part I and generate the content so that it is usable in Microsoft Office tools such as
Word, Excel and PowerPoint.

The second part of this course will take many of the examples used in the first part of the course and we will talk
about what customizations can be made using both the LAYOUT features of ODS along with the object model,
making this a very powerful tool in our arsenal of SAS tools. Note: Part I of this seminar is *highly* recommended
as we will build on the programs developed in the first section to help develop the application that will be written in
the second part.

4. SAS Programming for the Pharmaceutical Industry
Instructors:      Carol Matthews from BioCor
                  Brian Shilling from Applied Clinical Intelligence
E-Mail:  and

Carol Matthews is currently the Associate Director of Clinical Programming at BioCor, a CRO located in Yardley,
Pennsylvania. She has been programming in SAS ® for over ten years with the last seven years having been with
CROs. Carol has taught classes in Philadelphia University‘s SAS Programming Certification program since its
inception in 1998. The classes have covered topics including clinical data set concepts, reporting with Data
_NULL_, and the efficient use of macros in clinical programming. She is currently in the process of co-authoring a
book for SAS Institute‘s Books by Users program.

Brian Shilling is currently the Director of Quality Assurance at Applied Clinical Intelligence. He began working in
the pharmaceutical industry in 1984 and has been in the industry intermittently since that year, working for CROs
and large pharmaceutical companies. He has been a SAS programmer for 7 years. Brian has been a member of the
Pharmaceutical Industry SAS User Group Executive Committee for 5 years, has been a presenter for PharmaSUG,
PhilaSUG and Barnett International, and currently holds adjunct faculty status at Philadelphia University where he
teaches the SAS Programming Certification Course. He is also in the process of authoring a book for SAS Institute‘s
Books by Users program.

Pre-requisites:           Basic understanding of SAS, including basic statistical procedures (PROC FREQ,
                          MEANS, etc) and reporting methods
Intended audience:        Programmers new to the pharmaceutical industry
Course material:          Course notes

Course description:
SAS, as a programming language, has been in existence for over 25 years. SAS applications are utilized in many
different industries, including the pharmaceutical industry. The discipline of Clinical Trials within the
pharmaceutical industry is one of the largest and most rapidly increasing users of SAS, by virtue of the need for
intricate statistical analyses, reporting and summarization requirements, and high quality output. So what makes
programming in the pharmaceutical industry different from other industries? The FDA regulates the pharmaceutical
Since the pharmaceutical industry is a governmentally regulated industry, SAS programmers must adopt many
unique philosophies and techniques in order to meet strict FDA requirements. As a result, good programming
practices (GPPs) are a determining factor in the successful outcome of clinical trials.

The purpose of this half-day course is to educate the participants with respect to the key areas that programmers
need to focus on in order to shorten programming time, reduce errors, and meet or accelerate final timelines. Key
areas discussed include documentation methods and the most common SAS validation issues.


5. Intermediate and Advanced Topics of the SAS Macro Language: Moving Beyond the
Instructor:       Art Carpenter
Affiliation:      California Occidental Consultants

Art Carpenter‘s publications list includes three books, and over four dozen papers and posters presented at SUGI,
and various regional and local user group meetings. Art has been using SAS since 1976 and is a SAS Certified
ProfessionalTM. Through California Occidental Consultants he teaches SAS courses and provides contract SAS
programming support nationwide. He has written and presented extensively on the SAS Macro Language.
Pre-requisite:             Working knowledge of the basic components of the SAS Macro Language
Intended audience:         Good grounding in the base language of SAS and should be familiar with the
                           introductory aspects of the macro language. This should include use of the %LET, %IF,
                           %MACRO, %MEND, and %DO statements.
Course material:           Attendees will receive a complete set of course notes, including all examples

Course description:
This seminar provides an in depth look at all of the primary functions and statements used in the macro language.
Each is presented by example within the context of how it is used. At the end of the course the student will be able
to; use macro functions including evaluation and quoting functions, use DATA step functions within the macro
language, build and use macro arrays, implement macro libraries including autocall and compiled stored macro
libraries, create customized macro functions and utilities, and be able to utilize system and environmental
information in the macro environment. The course will include V8 and SAS9 updates to the macro language.


6. Analysis Data Sets in FDA Electronic Submissions: Concepts and Principles
Instructor:                David H. Christiansen, DrPH
Affiliation:               Christiansen Consulting

Dr. Christiansen is a consultant specializing in pharmaceutical regulatory electronic submissions. He earned his
Masters and Doctorate of Public Health in Biostatistics from the University of North Carolina at Chapel Hill. He is
co-founder of CDISC and leader of the Analysis Dataset Modeling (ADaM) Team. As Principal Biostatistician at
Genentech, Inc, he developed new technologies and processes for drug development and electronic regulatory
submissions. Dr. Christiansen was Research Assistant Professor of Biostatistics at UNC-CH, specializing in
statistical computing and research data management. He co-developed and taught a graduate level course entitled
―Clinical Trial Information Management‖ for FDA medical reviewers.

Pre-requisite:             Familiarity with FDA electronic submissions, clinical trials and SAS data set
Intended audience:         SAS programmers, biostatisticians, data managers and IT professionals involved in
                           electronic submissions of NDAs and BLAs to the FDA
Course material:           Handouts will be provided

Course description:
The emergence of electronic submission of New Drug Applications (NDA) and Biological Product Applications
(BLA) to the FDA has placed increased emphasis on the datasets included in these submissions. This course will
review the efforts of the FDA, NIH, Clinical Data Interchange Standards Consortium (CDISC), Health Level 7 (HL-
7) and others to provide models and standards for submission datasets, metadata and documentation.
Will focus on the analysis datasets used for statistical analyses performed to demonstrate the safety and efficacy of
new treatments. These analysis datasets contain variables from several of the clinical domains (labs, demographics,
etc.), as well as derived and imputed variables. The design, creation and documentation of analysis datasets will be
discussed in the context of recent FDA and International Conference on Harmonisation (ICH) guidelines on
electronic submissions. Concepts and principles of analysis dataset design will be discussed from the perspective of
the pharmaceutical sponsor submitting the data as well as that of the FDA statistical reviewer.
Tentative Course Topics Include:
         The Clinical Trial Process and Submission Datasets
         Review of Data Models and Standards: FDA Guidelines, CDISC, HL-7, others
         Analysis Dataset Model Concepts and Principles
         Analysis Dataset Model Standards and Examples (ADaM)
         FDA Guidelines on Analysis Datasets
         Design of ―One PROC Away‖ datasets
         Analysis Dataset Metadata
         Derived and Imputed Variables
         Submission of SAS Programs
         Future directions: Machine-readable metadata, XML, the ICH Common Technical Document.

7. Get Productive with Proc SQL: The Basics and Beyond
Instructors:               Justina Flavin from Pfizer
                           Richard Severino from the Queeen’s Medical Center
E-Mail:           and

Justina Flavin is a Senior Clinical Programmer/Analyst at Pfizer Global Research & Development, La Jolla
Laboratories. She has been employed as a SAS programmer in the pharmaceutical industry for twelve years. Other
SAS experience includes developing SPC charts and graphs for manufacturing processes in the aerospace industry,
and performing data analyses for research projects in the medical, psychological, and political fields. Justina is also
an instructor for SAS Programming courses at the University of California, San Diego Extension.

Richard Severino is a statistician and programmer at The Queen's Medical Center in Honolulu, Hawaii. Richard has
been using SAS since 1986 in a variety of disciplines. He has presented papers, including tutorials, at SUGI, WUSS
and PharmaSUG, where he won the Best Paper Award in 1999. He has given talks on Proc SQL to the SAS
programmers group at the Queen's Medical Center and also at the Hawaii SAS User Group (HISUG) meeting.
Richard earned the Master of Science degree in Statistics from San Diego State University.

Course description:
This course is for those wishing to learn Proc SQL as well as beginning to intermediate Proc SQL users. It is the
first part of a two-part course. Upon course completion, students will:
         be familiar with all options in Proc SQL
         have an understanding of differences and similarities between options
         be able to create tables and views
         be able to create detailed as well as summary reports
         know enough to be able to use Proc SQL to perform some basic data management tasks
         ready to learn advanced techniques (taught in Part 2 of this course)


8. Be More Productive with Proc SQL: Advanced Techniques
Instructors:      Justina Flavin from Pfizer
                  Richard Severino from the Queeen’s Medical Center

Course Description:
This course is for intermediate to advanced Proc SQL users. Upon course completion, students will be able to solve
more complex problems and produce more complex reports using Proc SQL. Topics to be covered include:
         nested subqueries
         incorporating Proc SQL into macro code
         uses of and subtle differences between tables & views, joins & unions and the "having" & "where" clauses
         querying tables from an external database
         joining SAS tables to external tables
         using Proc SQL to accomplish tasks which otherwise would require more advanced programming

9. Building a Dynamic Application Using the SAS Macro Language
Instructor:                Art Carpenter
Pre-requisite:             Strong working knowledge of the intermediate components of the SAS Macro Language
Intended audience:         Attendees should have a solid grounding in the base language of SAS, and should be
                           familiar with the intermediate aspects of the macro language. This should include use of
                           the major macro functions and statements, especially %SYSFUNC. Experience with the
                           dynamic programming aspects of the macro language is helpful but not required
Course material:           A complete set of course notes, including all examples

Course description:
This seminar provides the tools to take your SAS Macro Language programming skills to the next level! Create
reusable and generalized macros. Learn how to create groups of programs that are written without data
dependencies allowing the programs to determine their data dependent inputs dynamically. Attendees will not only
learn the macro language tools used to build dynamic programs, but also strategies for controlling the operating
environment. Topics include; writing data controlled macros, building control files (meta data), executing macros
dynamically, creating and using macro arrays to control processing, different forms of dynamic execution, and the
effective use of macro libraries.


10. Accurate Manipulation of Clinical Trial Data (Tricks, Traps, and Techniques)
Instructor:                Malachy (Mal) J. Foley
Affiliation:               University of North Carolina at Chapel Hill
E-Mail:                    FOLEY@UNC.EDU

Malachy J. Foley is a Senior SAS Programmer/Analyst in the Department of Biostatistics at the University of North
Carolina at Chapel Hill (UNC). Mal has worked with clinical trial data for over 15 years and research data for more
than 35 years. His career in computing includes being an international consultant, a department manager, a
university professor, and a CEO. He has taught dozens of computing courses at the undergraduate, graduate, and
professional levels. He frequently presents papers and gives seminars at local, regional, national, and international
SAS users‘ groups.

Pre-requisite:             Working knowledge of SAS DATA Step
Intended audience:         Anyone who merges, combines, or otherwise manipulates SAS data sets
Course material:           70-page book

Course description:
The most overlooked source of data error in clinical trials is the area of combining and manipulating SAS data sets.
This seminar discusses over 30 common errors in merging data from labs and case report forms. All of these errors
result in erroneous data. Many of them occur with no SAS message or warning!
In addition to examining errors, the seminar covers a wide range of topics needed to accurately obtain data for
statistical analysis. These topics include interleaving, subsetting, concatenation, check digits, BY-variable
processing, the IN=data set option, FIRST.variable, program data vectors (PDV), cartesain products, one-to-one
merges, match merges, and fuzzy merges.

The seminar starts with the basics and continues to build to complex and tricky examples of data set manipulation.
During the seminar, questions are encouraged. The only prerequisite for the course is a working knowledge of the
SAS DATA Step. Yet, this seminar will give intermediate and advanced programmers a great review and some
surprises. Come see what mysteries lurk in manipulating SAS files!

11. Introduction to XML for Data Exchange Between SAS and Other Platforms

Instructors:              Miriam Cisternas and Ricardo Cisternas
Affiliation:              MGC Data Services

Ricardo and Miriam Cisternas are principals of MGC Data Services, a SAS Alliance partner that provides analysis
and web-related services to the research and pharmaceutical industries. Ricardo Cisternas has built database and
web systems using Java and XML technologies, and has taught computer programming at the university level.
Miriam Cisternas is a SAS Certified Professional who has been using SAS for over a decade to analyze and manage
a variety of primary and secondary data. Ms. Cisternas has chaired the internet section at the Western Users of SAS
Software conferences, and has been an instructor for the University of California, Berkeley.

Pre-requisite:            Experience with HTML and Base SAS
Intended audience:        SAS Programmers and applications developers who want to use XML to exchange data
                          between the SAS System and other platforms. If you are interested in XML but could
                          use some help getting started reading and writing XML files from SAS, then this class is
                          for you.
Course material:          Overheads and handouts will be provided. Electronic versions of materials will be
                          provided after class upon request

Course description:
This seminar shows SAS programmers how to apply the power of XML (eXtensible Markup Language) to exchange
data between platforms and applications. The seminar is filled with numerous examples of how SAS Software
interfaces with XML, both in Version 8.2 of the SAS System and in the upcoming release of Version 9 of SAS
software. The code examples and demonstrations unlock the mystery and power of XML for SAS users and will
show you how you can apply XML within the SAS System in your daily work.

General Concepts
       What is XML and how does it differ from HTML?
       Comparison: the relational vs. hierarchical data models.
Writing XML Documents: Building Blocks
       Elements—the building blocks for all XML documents
       Getting starting writing your first XML document: the XML declaration
       Using comments to document your XML Documents
       Viewers and tools for authoring XML files
       Using XML name spaces to avoid tag name conflicts
How to read/write Simple XML files using SAS
       Simple and complex XML data hierarchies (rectangular vs. non-rectangular data).
       Using the XML Libname statement to read and write rectangular data from XML documents.
Introduction to XML Document Validation
       Exploiting the document modeling capabilities of XML: validating the content and structure of documents
        against a set of rules.
       Using DTDs to describe data and validate XML documents
       Improving the description of your data using XML Schema (XSD)
       Using XML Schema to understand the structure of XML files provided by others
How to read/write Complex Hierarchical XML files using SAS
       Reading complex hierarchical data to SAS: the XMLMAP option on the LIBNAME statement and the new
        XML Atlas application (production in 9.1).
       Writing non-rectangular data using the default output and ODS MARKUP
       XML standards for the Pharmaceutical Industry: CDISC
       Programmer Resources for using XML with SAS

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