2003 Past Meetings and Presentations -- 2003

13-17 January 2003 - Health Level 7 Working Group Meetings San Antonio, TX

The next Health Level 7 Working Group Meetings will take place in San Antonio, TX in January. The Regulated Clinical Research Information Management (RCRIM) Technical Committee is a collaborative opportunity among HL7, CDISC, and FDA. Meetings are open. For more information, please visit the website at www.hl7.org. CDISC representatives can attend as HL7 members.

23-24 January 2003 - DIA Clinical Data Management Workshop Tokyo, Japan, Tokyo Conference Center

For the DIA CDM Workshop, Mineko Fujimoto of Nihon Schering K.K., who is serving on the program committee, has invited CDISC presentations. More specific information will be available at a later date.

3-5 February 2003 - Clinical Technologies Congress Philadelphia, Wyndham Franklin Plaza

The 2003 Clinical Technologies Congress, February 3-5, 2003 in Philadelphia, is a large-scale, multi-track pharmaceutical industry event addressing opportunities to leverage and integrate technologies throughout clinical trials. The comprehensive program will bring together representatives from CROs, sponsors, investigative sites and other professionals to collaborate; it will address the challenges in technology selection, implementation, management, and acceptance.

Specific topics to be addressed include:

• Improving Data Collection and Processing through EDC Technologies
• Integrating Medical Records and Clinical Trial Management
• Applying Clinical Trial Simulations to Make Better Drug Development Decisions
• Blended E-Learning: Training a Worldwide Clinical Staff
• Ensuring Regulatory Compliance Throughout Clinical Trials

The event includes Keynote and Plenary presentations by:

Alpheus Bingham, PhD - Vice President, e.Lilly, ELI LILLY & CO.
Sylva Collins - Vice President, Electronic Data Capture, NOVARTIS
Ira Katz - Vice President, Drug Evaluation Clinical Operations, JOHNSON & JOHNSON
Rebecca Kush, PhD - President, CDISC
Kenneth Getz, MBA, CenterWatch

Barbara Tardiff, M.D. Ph.D. of REGENERON will speak on progress in the HL7 Regulated Clinical Research and Information Management (RCRIM) Technical Committee, which is co-chaired by representatives of CDISC, FDA and HL7.

For more details, please visit www.clinicalevent.com

10 February 2003 - DIA Workshop: Database Standards in Clinical Research: An Operational Perspective
Philadelphia, Hyatt Regency at Penn’s Landing

This workshop will cover the following topics:

• An overview of Clinical Data Management – From Data Capture to Analysis Database
• Balancing Between Internal Clinical Data Management Process Nees and External Factors
• Cost Benefit of Implementing CDISC Standards
• Return on Investment of Virtual Database

Frank Newby (CDISC) and Michele Thomas (GSK) have been requested to speak at this workshop. Another speaker will be selected to complete the session. Abstracts are due by 1 November to the DIA (www.diahome.org).

The Pharmaceutical industry has been regarded as slow to adopt technical innovations. Many believe it’s time for Pharma to re-think their strategies and pay attention to positive study results. At this conference, we will showcase these successful results and focus on how you can implement proven strategies and processes in your clinical development programme.

You will hear from many experienced clinical professionals, including:

• Stacey Wills, MPH, PhD, Associate Director, Pharmacia
• Stephane Rouault, Director of European Data Management, Aventis
• Udo Siegmann, Member of Board, CDISC
• Hans Peter Marschall, EDC Project Leader, Bayer
• Mikael Palmblad, Technology Watch-EDC, AstraZeneca
• Michael Herschel, Head of Clinical Trails, GlaxoSmithKline
• Robert Musterer, Director Clinical Systems, Bayer Corp

CLICK HERE for further information.

We also wish to thank IIR for their contribution to the CDISC organization.

17-18 March 2003 The New Business of Clinical Trials: Addressing Solutions in Cost, Quality & Time Philadelphia, PA

Charles Jaffe, MD, PhD, AstraZeneca and CDISC Board, has assisted in the development of this workshop, and Frank Newby will be speaking at this event, which is hosted by Pharmaceutical Education Associates. The New Business of Clinical Trials: Addressing Solutions in Cost, Quality & Time conference will take place at The Union League of Philadelphia. This event offers cutting-edge information to assist with the decision-making processes associated with managing clinical trials. Hear from top experts in the industry and arm yourself with the tools to tackle today’s clinical trial issues. To register, or for more information, call 800-686-2276 or visit www.pharmedassociates.com. A specific website for the conference is the following.
http://www.pharmedassociates.com/regulatory.asp#p112

27-28 March
eClinical Trials and Data Management
London, UK

Johann Breuning of Schering AG will be making a presentation on “CDISC: The Practical Challenges of Implementation” to open this workshop, which is sponsored by IQPC www.iqpc.co.uk. We also appreciate the willingness of IQPC to make a contribution to the CDISC organization.

30 March – 2 April
DIA Clinical Data Management Conference
Philadelphia, PA

This year the DIA CDM Conference will include an Introduction to CDISC Tutorial on Sunday, 30 March, which will be taught by Frank Newby and Rebecca Kush. A session on CDISC will include the presentations/speakers listed below. There will also be a round table discussion on CDISC at noon on Monday, 31 March.

Recent Progress and Implementation Experience with CDISC Standards

Session Chair: Rebecca Kush, PhD

Open industry standards to facilitate the acquisition, exchange, submission and archive of electronic clinical trial data are now available. This session will begin with an overview of the recent progress of the Clinical Data Interchange Standards Consortium (CDISC), including collaborations with other organizations interested in data standards. There will be three speakers, who will focus on their first-hand experiences implementing CDISC standards within the US and Europe. They will discuss benefits and provide recommendations for meeting challenges that were incurred. The last presentation will also include an overview of work in progress by the Protocol Representation group within the HL7 RCRIM Technical Committee, which represents collaboration among FDA, HL7 and CDISC.

1. Implementing CDISC ODM in a clinical data exchange system
   Murray Resinski, Clinical eBusiness
   Schering-Plough Research Institute
2. Problems and solutions implementing CDISC standards in CDMS and data analysis
   Herbert Noack, PhD
   Covidence GmbH
3. A low maintenance, Vendor-Neutral Clinical Data Gateway Based on CDISC Standards
   Michael C. Palmer
   Zurich Biostatistics

8-9 May 2003
Annual E-Clinical Trials Forum
The Mirage Resort, Las Vegas

Vision in Business is sponsoring a comprehensive program tackling eClinical Trials issues that can help move you beyond the pilot phase and unleash the full potential of the Internet to accelerate clinical trials. This is an opportunity for you to benchmark with other organizations as we create an open environment where discussion and debate can take place at the highest level.

Speakers include:

Charles Jaffe, Director of Medical Informatics, Astra Zeneca
Susan Bassion, LAB Team Leader, CDISC
Peter Holte, Director Data Management & Clinical Systems, Roche Diagnostics
Rob Case, EDC Development Manager, Procter & Gamble Pharmaceuticals
Barbara Malunga, International Clinical Auditor, F. Hoffman La Roche
Amy Schwarzhoff and David Smithwick, Chesapeake Research Review
Ron Marks, University of Florida
Representatives from a number of key vendor companies

To register please call +44(0)20 7953 7450 or email postmaster2@visioninbusiness.com
http://www.analysisandnetworking.com/elink.taf?EventUid=100289&CatUID=3&id=12312CDIS

13-15 May 2003
Applied Clinical Trials European Summit
Management Centre Europe, Brussels

Udo Siegmann (Parexel), Leader of the European CDISC Group and Director on the CDISC Board, will be presenting on CDISC at this Applied Clinical Trials European Summit. We very much appreciate the contribution from ACT to CDISC, in addition to covering travel expenses for the speaker

21-22 May 2003

Clinical Data Interchange Standards Consortium (CDISC) announces:
2nd Annual European CDISC Meeting
Hosted by Enterprise Ireland, Dublin, Ireland

Day One (21 May): Introduction to CDISC Course
Day Two (22 May): European CDISC Group Conference

To determine costs to attend either or both of these events and to register, e-mail swilliams@cdisc.org.

For more information on the European CDISC Group, please e-mail udo.siegmann@parexel.com.

13-17 June 2003
DIA Annual Meeting
San Antonio, TX

There will be three sessions devoted to the new DIA eClinical and Standards Special Interest Area Community (SIAC) at the Annual Meeting this year. These are all on Monday, 16 June.

• New Technologies/Processes: Integration Aspects--John Weiler, Chair
• Technology Adoption--Charles Jaffe, Chair
• CDISC: Collaborative Progress in Information Sharing—Rebecca Kush, Chair
  • Speakers in the latter session include Dr. Randy Levin (FDA), Susan Duke and Diane Wold (GlaxoSmithKline), and Katherine Hollinger (FDA)
    

Additional sessions that will include information directly relevant to CDISC are the following:

• Regulatory Initiatives in HL7: Using XML and Structured Documents—Chair, Michael Palmer (Tuesday, 17 June)
• CDISC Standards in Practice: Actual Examples Where the Use of CDISC Standards Addresses Data Management Issues—Chair Mohammed Al-Ansari (Tuesday, 17 June)
• The Review Process – Parts 1 and 2: The CTD and it’s Impact on the Review Process at FDA, Chair—Peggy Boe (Tuesday, 17 June)
• Electronic Drug Development Standards – Parts 1 and 2 – Chair, Wayne Kubick (Wednesday, 18 June)
• Processing and Reviewing Electronic Submissions in CDER –Chair, Randy Levin (Wednesday, 18 June)
  

Also, watch for the eClinical and Standards SIAC Luncheon Meeting from 11-2. It will be either Tuesday (17 June) and is open to anyone interested in these topics across clinical trials.

CDISC will have a booth in the Exhibit area. (We are not doing a connectathon this year.) Suggestions for CDISC demos and individuals who would like to spend an hour or so working with the CDISC Operations staff at the booth are welcome. Please contact Shirley Williams (swilliams@cdisc.org)

17-18 June 2003
HL7 Educational Summit
Holiday Inn Chicago City Centre
300 East Ohio Street
Chicago, IL 60611

The HL7 Educational Summit is a concentrated two-day schedule of tutorials focused on HL7-specific topics such as Version 2.x implementation, the Clinical Document Architecture (CDA) and the Clinical Context Management Specification (also known as CCOW) among others. Educational sessions also branch out to cover general interest industry topics such as HIPAA, XML and more.

This is an outstanding educational opportunity that is invaluable to the healthcare IT community as it strives for greater interoperability among healthcare information systems. Our classes offer a wealth of information designed to benefit a wide range of users — from beginners to the more advanced HL7 users.

FREE CERTIFICATION TESTING TO FIRST 50 REGISTRANTS!

The Educational Summit will also feature HL7 Certification Testing. FREE Certification Testing will be provided for the first 50 who register!

For sponsorship details and meeting registration information, contact
Peggy Bitondo at (734) 677-7777

July 21 and 22 in King-of-Prussia, Pennsylvania
July 24 and 25 in East Hanover, New Jersey
CDISC Educational Seminars
CDISC, HL7, and XML: Simplified and De-Mystified
Organized and Chaired by Michael Palmer, Zurich Biostatistics

Topics to be covered include: the In just two days of intensive training by FDA and pharmaceutical industry experts, you will know more about CDISC, HL7, and XML than most pharmaceutical professionals and know precisely how to apply what you know immediately to your organization's operations. A world-class team will guide you through the intricacies of standards implementation. Instead of poring over
detailed standards documentation yourself, you will get the streamlined,
simplified story straight from professionals who actually write the regulations at the FDA and use them in major pharmaceutical companies. You will understand CDISC, HL7 and XML in the real world, in actual applications. It's faster, and more efficient. FDA's clinical data and XML initiatives, CDISC's new Submissions Data Model version 3 and transitioning to it, using CDISC's XML-based Operational Data Model and Submissions Data Model as one for a universal data transport and archiving framework.

For more information, please e-mail Frank Newby, VP, Education and Member Relations (fnewby@cdisc.org) or see the CDISC website Education area.

First Annual CDISC Interchange Very Successful!!
Dr. McClellan Expresses Solid Support for CDISC

The first annual CDISC Interchange was held the week of September 29 in Bethesda, Maryland. The Interchange consisted of tutorials, workshops, exhibits, team meetings and the conference, which included the keynote address by Dr. Mark McClellan, FDA Commissioner.

The first day included tutorials on an Introduction to CDISC and Submission Data Standards (SDS) Version 3. The CDISC standards development teams also met on Monday. At the end of the day, the CDISC Board of Directors hosted a reception for the team members, and awards were given to the team leaders and to outstanding members of each team.

Steve Ruberg, CDISC Board of Directors
Chair, at the Team Awards Presentation

The recipients for the awards for outstanding contributions to CDISC were presented as follows:

SDS – Submission Data Standards Team Tom Guinter – Sanofi Synthelabo Diane Wold – Glaxo Smith Kline ODM – Operational Data Model Team Craig Schaffert – Lincoln Technologies Michael Palmer – Zurich Biotechnology Inc. ADaM – Analysis Data Models Team Michael Nessly – Merck LAB – Laboratory Data Model Team Phil Pochon - Covance Mike Kerzee – IBM
	Craig Schaffert - ODM	Michael Nessly - ADaM
	Michael Palmer – ODM	Tom Guinter - SDS

Not pictured: Mike Kerzee – LAB, Diane Wold - SDS

On Tuesday, the exhibits opened, four workshops were presented (and all reached/exceeded capacity for attendees) and a tutorial on the CDISC LAB Model was provided. The CDISC teams met jointly to discuss shared issues, and an early evening reception for all participants gave everyone a chance to “Interchange” ideas. The last meetings of the evening were round table discussions on Education, Membership and Public Relations/Communications.

Shirley Williams, CDISC Director of Finance and Operations, Greets Registrants

On Wednesday, the conference opened with a keynote address by Dr. Mark McClellan, FDA Commissioner. Dr. McClellan was very supportive of the CDISC effort to develop standards and their important role in moving the industry and FDA forward.

FDA Commissioner Mark McClellan with CDISC President Rebecca Kush after Keynote Address

The conference continued with presentations about the state of the industry, the status and goals of CDISC, the future of technology. There were presentations on CDISC Japan and CDISC Europe. The afternoon included updates and implementation examples of the CDISC standards.

Presentation slides from the Interchange can be found on the CDISC website under “Presentations”.

On the afternoon of 3 October, following the FDA Public Meeting on eSubmissions, there was a CDISC Industry Advisory Board Meeting (representatives of each of the CDISC Corporate Sponsors). There were over 40 attendees, who discussed a number of topics, including the CDISC-HL7 relationship and the CDISC Strategic Plan 2004-2006. Randy Levin of FDA was there to answer questions.

The 3 days were well attended, with total participation of well over 250. Stay tuned as plans are currently being made for CDISC Interchange 2004.

27-28 October 2003 - IIR Case Report Forms Conference
Radisson Plaza – Warwick Hotel

Presentations will include a “Coach’s Corner” to include Dr. Charles Jaffe, AstraZeneca and CDISC Board of Directors and a presentation on CDISC-CenterWatch Research results supporting standards for data collection. (See www.iirusa.com/casereportform.)

Note: 20% discount if you mention you saw this event on the CDISC website!

29-30 October 2003 - DIA Workshop: “Technology at the Investigative Site”
Planning and Implementing eClinical Trial Solutions to Improve Performance
Marriott Washington Hotel, Washington DC

This workshop will focus on how new technologies have changed the landscape for clinical investigators, current trends in the use of technology at investigative sites and success and failures of using new technology to bring drugs to market. (See www.diahome.org.)

30-31 October 2003 - DIA Workshop: “Electronic Patient Reported Outcomes (ePRO) and the Regulatory Process: What’s Going On?”
Marriott Washington Hotel, Washington DC

This workshop will focus on the regulatory aspects of using technology for collecting patient-reported information in clinical research. (See www.diahome.org.)

3-5 November 2003 - 13th Annual DIA European CDM Meetings
“CDM – The Clinical Trial Engineers”
Basel, Switzerland

Program Co-chairs for this are Barry Burnstead, Phase Forward Europe Ltd., UK and Pierre-Yves Lastic, Sanofi-Sythelabo, France. There will be a tutorial on Monday, 3 November on “Regulatory Submission and Review of Clinical Trial Data at the FDA”. This will be led by Dr. Pierre-Yves Lastic and will include Dr. Randy Levin, FDA and Dr. Stephen Wilson, FDA. There will also be a session on CDISC. (See www.diahome.org)

6 November 2003- CDISC Strategic European Member Meeting
Basel, Switzerland

25th & 26th November 2003- The Engineer’s Integrated e-Systems in Clinical Trials
Café Royal, Central London.

This innovative, pan-European conference deals with subjects at the strategic, regulatory and operational levels with all topics tied to the central concern; what improvements in your time-to-market and overall profitability will electronic systems product?

As a result of in-depth research, this event will tackle the following HOT topics;

• How do I decrease the time it takes to get a product to market?
• How can we avoid spending so much time recopying information between databases?
• What can I do to increase efficiency within my clinical trial process?
• Who could I look to for examples of how to solve these problems?
• Do Electronic Clinical Systems justify the price tag?
• What would I have to do to satisfy the demands of the regulators?

2nd - 4th December 2003
Eden Roc Resort & Spa, Miami Beach, Florida, USA

Aligning & Integrating Business and Scientific Processes with IT to Enable Information Integration and Effective Decision-Making in Drug Discovery and Development

The Drug Discovery & Development Information Integration Congress 2003 (DDDII) will feature over 40 cutting-edge case studies, interactive discussions and presentations from the leading Pharmaceutical and Biotechnology companies who are leading the way in the area of information integration across the Discovery & Development enterprise. Charles Jaffe, Director of Medical Information/AstraZeneca and Director on the CDISC Board will be one of the keynote speakers. For more information, use the following link: http://www.wbresearch.com/DDDII/.