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