XML and Pharmaceutical Data Management Summit 2003

Date of snapshot: 2003-05-20. From: http://www.cptpharma.org/



XML and Pharmaceutical Data Management Summit 2003
Understanding Evolving Standards for Clinical Data Management and
Regulatory Submissions
September 23 - 24, 2003  Philadelphia, Pennsylvania
From: http://www.cptpharma.org/
See: http://xml.coverpages.org/conf.html#pharma2003
Conference Agenda
Pre-Conference Workshops:

Workshop A: Creating, Managing And Publishing Manufacturing Batch
Records In Real-Time With XML
Workshop B: Controlling Data Quality In Real-Time Applications
Workshop C: Using Effective IT Management To Implement A Reliable
Electronic Safety Reporting System
Day One: Tuesday, September 23, 2003
8:00 - Registration and Continental Breakfast
8:30 - Chairperson's Welcome and Opening Remarks
Liora Alschuler
Consultant, Co-Chair, Structured Documents Technical Committee
HL7
8:45 - What is Health Level 7?
Keynote Address
Health Level 7 is a healthcare ANSI-accredited Standards Developing
Organizations focusing on "standards for the exchange, management and
integration" of clinical and administrative data. This double session
focuses on the history of HL7, HL7's technical infrastructure and the
main initiatives and their stages of development. Key topics include:

What is HL7?
Using XML for clinical information capture and processing
RCRIM: HL7's collaboration with CDISC and FDA
Understanding the Clinical Document Architecture: Clinical Trials and
Drug Labeling
Liora Alschuler
Consultant, Co-Chair, Structured Documents Technical Committee
HL7
10:15 - Morning Refreshment Break
10:30 - Banish Babble, Speak With One Voice: CDISC Standards for
Clinical Data
Standards work. Pharma IT departments facing the tasks of importing
clinical trials data in-house from diverse, even alien, systems and of
transporting this data within systems composed of diverse sub-systems
and applications are beginning to believe in the utility of CDISC
standards. CDISC standards are seen as the way to develop robust,
smart systems that discourage poor software practices. Key topics
include:

Learn what Pharma companies have done with CDISC's XML standard for
clinical data, ODM
See the clinical data paradigm ODM is built on and understand how it
relates to your every day work
Understand how XML .ts in to the clinical data scene and what
advantages it brings
Unjumble the alphabet soup of standards and standards organizations
Peek into the collaboration of industry, FDA, CDISC and HL7 that is
delivering new XML-based standards to Pharma R&D
Michael Palmer
President
ZURICH BIOSTATISTICS
11:15 - Using CDISC as a Common Interface Between Applications
Case Study
Is CDISC another buzzword or can it be effectively used in Clinical
Trials? This case study demonstrates a production scenario of the
CDISC-ODM model running RDC Clinical trials and submitting data to a
legacy CDMS. The case study explores the experience of using CDISC-ODM
to build a real-time data-hub between disintegrated systems, the
extensions to the ODM model and its compatibility with ODM and
internal databases. Furthermore, strategies are outlined for using
XForms layout W3C standards and utilizing it to design the form once
and make it available for paper, html, Windows GUI, etc. Key topics
include:

Pros and cons of CDISC-ODM in RDC
CDISC XML as real-time data hub between disparate systems.
Extensions of the CDISC model to support our legacy applications
Introduction of Xform W3C standard
Reusability of XML applications
Munther Baara
Associate Director, Global Clinical Applications
WYETH
12:00 - Luncheon for Speakers and Delegates
1:30 - Implementing the CDISC ODM in Your Enterprise: When and How
Case Study
The CDISC Operational Data Model (ODM) is a complex new XML standard
that promises to revolutionize data management in clinical trials.
Your enterprise needs to know when and how to exploit this technology
to compete and meet regulatory requirements in an increasingly
technology-driven market. This session focuses on the practical
implications of several fundamental trends in EDC and XML to help you
implement the ODM in your enterprise. Key topics include:

Exploring how EDC adoption will drive XML adoption generally, and ODM
adoption in particular
Developing techniques for evaluating EDC vendors by the type and
quality of XML support in their products
Examines where recent XML advances will take the ODM and how you can
prepare for these changes
Details transitional strategies for leveraging your current
technological and human capital investments while migrating to XML-
driven data management practices
Shares Nextrials' experience with implementing the ODM in Prism(R)
Robert Lyons, PhD
Chief Technology Officer
NEXTRIALS, INC.
2:15 - Utilizing HL7 Clinical Document Architecture for Regulatory
Product Information Labeling Submissions
The prescription drug label, or package insert, is highly structured,
containing tightly de.ned required and optional components. Submitting
required changes to FDA whenever a label is changed or altered, is
both time consuming and costly in that the necessary elements may be
in different documents or formats. In concert with FDA, HL7 is working
on a structured product labeling speci.cation based on the HL7
Clinical Document Architecture (CDA). Key topics include:

An overview of the Clinical Document Architecture
Requirements for structured product labeling
Relationship of structured product labeling to CDA
The future of structured product labeling
Sandra Boyer
Consultant Editor
CDA
3:00 - Afternoon Refreshment Break
3:15 - Planning and Preparing for CDISC: XML Use in Clinical Data
Management at AstraZeneca
Case Study
AstraZeneca is using XML for application and data integration
including the development of a coding tool that translates data to the
in-house clinical data management systems. This case study details how
CDISC standards can help consolidate and standardize XML use in
clinical data management within the company and facilitate
collaboration with external organizations. Key topics include:

Planning for CDISC implementation, identifying key applications and
processes that would bene.t from the CDISC model
Standardizing data integration internally and externally
Determining current XML use and bene.ts of adopting standards
Estimating time and money saved not building customized data exchange
and transfer applications.
Daniel Ringenbach, MS
Sr. Manager, Clinical Data Management IS
ASTRAZENECA
4:00 - HL7 and CDISC Panel
Didn't get a chance to ask the speakers some of your most pressing
questions? Now is your chance! Don't miss the lively discussion that
is sure to follow about HL7 and CDISC.
Moderator:
Liora Alschuler
Consultant Co-Chair, Structured Documents Technical Committee
HL7
Panelists:
Sandra Boyer
Consultant Consultant Editor
CDA
Robert Lyons, PhD
Chief Technology Of.cer
NEXTRIALS, INC.
Daniel Ringenbach
MS Sr. Manager, Clinical Data Management IS
ASTRAZENECA
Michael Palmer
President
ZURICH BIOSTATISTICS
Munther Baara
Associate Director, Global Clinical Applications
WYETH
4:45 - Chairperson's Day One Closing Remarks
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Conference Agenda
Day Two: Wednesday, September 24, 2003
7:45 - Continental Breakfast
8:30 - Chairperson's Day Two Opening Remarks
Liora Alschuler
Consultant, Co-Chair, Structured Documents Technical Committee
HL7
8:45 - Large-Scale EDC Deployment
Keynote Address
Novartis has successfully deployed EDC in large-scale. Bene.ts in
speed, time, and quality are dramatic and irrefutable. Cost of
implementation was small in proportion to bene.ts and technical
obstacles were manageable. Other components of e-clinical trials (for
example, Patient e-diaries, IVRS, lab data, ECGs, study management
data, and performance metrics) are candidates for integration. This
presentation describes:

Business process re-engineering which led to these results
Strategy which contributed to results to date and which is guiding our
actions for the present and future
Key success factors and pitfalls to be avoided are discussed
Sylva Collins
VP, Electronic Data Capture
NOVARTIS
9:30 - Single-Source Clinical Trial Reporting: Duke Clinical Research
Institute Case Study
Case Study
Duke Clinical Research Institute has embarked on a pilot project using
HL7's CDA and CDISC's ODM to address the problem of data gathering for
clinical trials. This case study will contrast previous approaches to
"esource" or electronic data capture (EDC) with a document-centric
singlesource data collection and presents preliminary results from
this groundbreaking pilot. Key topics include:

The challenge of single-source reporting
Document-centric approaches
Previous approaches to e-source
The Duke Clinical Research Institute pilot trials: preliminary results
Conclusion
Liora Alschuler
Consultant, Co-Chair, Structured Documents Technical Committee
HL7
10:15 - Morning Refreshment Break and Hotel Check-Out
10:45 - Assessing the Impact of Part 11 on Long-Term Data Archiving
for EDC
Case Study
Most major Pharmaceutical and Biotechnology companies have an EDC
initiative in place and implementation goals of conducting clinical
studies using EDC anywhere between 10%-80% by 2004. Many vendors can
now offer clinical trial/data management software for the healthcare
industry that often includes the capabilities of electronic data
collection (EDC), trial management, diaries etc. However, most
software systems seem to be inadequate for providing solutions for
long-term data archiving. As the industry embraces the concept of
electronic clinical trials, there will be increased emphasis on long-
term storage of electronic records as per the Part 11 guidance. This
presentation includes one company's experiment of adopting XML as a
tool for long-term data archiving. Issues to be discussed include:

EDC challenges in the fast paced clinical trials in consumer
healthcare environment
Practical issues in compliance with key aspects of Part 11 guidance
Experience of using XML as a tool for long term data archival
Rajesh N. Patel
Team Leader, Data Management & E-Technology
GLAXOSMITHKLINE
11:30 - Standards Based Messaging for FDA Reporting
The presentation introduces FDA's use of national standards for drug
safety and stability reporting. We cover the rationale for using a
national standard, introduce Health Level 7 and the proposed HL7
Safety and Stability messages. The presentation also covers the use of
XML as the syntax for message transport and provide directions to
follow in planning for implementing the HL7 messages for FDA
reporting. Key points include:

Be introduced to HL7 clinical data standards
Learn about FDA requirements for messaging
Learn about HL7's use of modeling to create quality interface
standards
Understand HL7's use of XML as a transport mechanism for messages
Discover the key issues for implementing the proposed HL7 messages
Mead Walker
Consultant
MEAD WALKER CONSULTING
12:15 - Luncheon for Speakers & Delegates
1:45 - Pharmaceutical XML 101
XML technology is the ideal tool for streamlining business processes
in the pharmaceutical industry. XML can help organizations simplify
internal data management, content management and external
communications regarding regulatory submissions. The session provides
a non-technical overview of XML, discuss possible applications in
pharmaceutical content and data management, and review major authoring
tools.

A history of XML
A discussion of business processes across the enterprise that are
driving adoption of XML-based technologies
XML tools utilized for document authoring, assembly and management
(including Word 2003)
Jean L. Kaplansky
Systems Analyst, Global Document Solutions
PFIZER GLOBAL R&D
3:15 - Q&A Panel:
Didn't get a chance to ask the speakers some of your most pressing
questions? Now is your chance! Don't miss the lively discussion that
is sure to follow about XML.
Moderator:
Liora Alschuler, Consultant
Co-Chair, Structured Documents Technical Committee
HL7
Panelists:
Sylva Collins
VP, Electronic Data Capture
NOVARTIS
Jean L. Kaplansky
Systems Analyst, Global Document Solutions
PFIZER GLOBAL R&D
Mead Walker
Consultant
MEAD WALKER CONSULTING
Rajesh N. Patel
Team Leader, Data Management & E-Technology
GLAXOSMITHKLINE
4:15 - Chairperson's Closing Remarks & End of Conference