2002 Past Meetings and Presentations -- 2002

7-11 January 2002: HL7 Working Group Meetings, San Diego, CA; Clinical Trials Special Interest Group (CT-SIG) will convene 9-10 January during these meetings. Register online by 12 January 2002! (One can register as a CDISC representative by informing Shirley Williams that you would like to attend and obtaining the CDISC HL7 membership number from her.) Conference schedule at www.hl7.org. Agenda for CT-SIG available from rkush@cdisc.org.

14-15 January 2002: CDISC Board of Directors Meeting, Austin, TX.

25 January 2002: The Clinical Data Interchange Standards Consortium (CDISC) has been invited to provide four presentations on 25 January beginning at 13:45 at the Drug Information Association's Fifth Annual Workshop for Clinical Data Management meeting, which will be held at the Tokyo Conference Center, Tokyo, 24-25 January 2002. The following topics will be covered.

*Overview of CDISC - Stephen Ruberg, Ph.D., Director, Clinical Data Technology and Services, Eli Lilly & Company; Chairperson of the CDISC Board of Directors

*FDA Viewpoint of CDISC - Steve Wilson, Ph.D., U.S. Food and Drug Administration

*Pharmaceutical Company Viewpoint of CDISC - Elaine Job, Global Head, Data Management Standards, Aventis Pharmaceuticals; Chairperson of the CDISC Industry Advisory Group

*European Experiences Implementing CDISC - Udo Siegmann, M.D., PAREXEL GmbH, Germany; Leader of the CDISC European Contact Group

There will be associated discussions regarding the initiation of a CDISC Group in Japan and a follow-up meeting in April 2002. If you need further information, please see the DIA website (www.diahome.org) .

3-6 February 2002: Society of Clinical Data Management, Annual Fall Conference (postponed from September 2001) will be held in Seattle, Washington. CDISC will have a tutorial organized and provided by Kaye Fendt and Sally Cassells (PHT Corporation). Other discussions of relevance to CDISC include a Plenary Session the evening of 5 February on the Good Clinical Data Management Practices Guidance (GCDMP), with a focus on metrics of clinical trials, facilitated by Rebecca Kush and a presentation on "What's Possible in CDM when you become E-nabled" by Pam Hrubey (Eli Lilly).

13-15 February 2002: "CDISC and Clinical Trials" will be presented by Graham Bunn (Quintiles) in the eClinical Session (Track C, Thursday 14 February) at IBC's 6th Annual InfoTech Pharma Congress 2002, which is scheduled to be held in London, UK.

11-14 February 2002: 2nd Annual Pharma R&D Directions Conference "Where Research and Development Meet" will be held in Cancun, Mexico. 12-14 February 2002 Ritz Carton, Cancun

Key topics this year are:

• Accelerate your potential through effective collaborations
• Optimising the relationship between bioinformatics and e-R&D
• Capitalising on the proteomic revolution to speed new drugs to market and increase company profit
• Merging insilico modelling and simulations with data monitoring analysis to revolutionise R&D

A CDISC presentation (co-authored by Drs. Rebecca Kush and Stephen Ruberg) is scheduled for the afternoon session on 13 February, along with a presentation on the Common Technical Document (CTD and eCTD) by Dr. Caroline Loew (PhRMA). See www.pharma-rd.net. Download the Conference Brochure. (pdf). Get ahead of the competition in Cancun!

18 February 2002 - Tentative date for next Industry Advisory Board Meeting, to be hosted by Elaine Job, IAB Chairperson, at Aventis Pharmaceuticals, Bridgewater, NJ. This is a meeting for the IAB representative from each of the CDISC Corporate Sponsor companies.

20 February 2002 - An IIR Conference In/Sites "Preparing for the Future Demands of Tomorrow's Clinical Trials" will include a workshop on the issues of web-based clinical trials presented by Felix Khon-Maung-Gyi (Chesapeake Research Review), and Drs. Steve Raymond (PHT Corporation) and Rebecca Kush. This is particularly relevant for investigative site personnel.

4-7 March 2002: The 2nd Annual eClinical Trials Conference organized by Vision in Business will be held at the Don CeSar Beach Resort in Tampa, Florida (see brochure -- PDF)

Speakers will include: Dr. Rebecca Kush on CDISC; representatives of Schering Plough Research Institute providing a Keynote presentation on 'EDC-Implementation and Validation from the Industry Perspective'; Dr. Ron Marks of the University of Florida presenting on current and emerging issues of eClinical Trials; Dr. Charles Jaffe of AstraZeneca presenting on investigators' needs and perspectives; Michael Fieseler of DataTrak presenting on benchmarking EDC internet technologies against paper-based trials; Matthew Whalen and Felix Gyi on human subject protection in a universe of e-solutions; Thomas Quinn from The Hollis Group presenting on confidentiality for Internet-based trials; and others from PHT Corporation, Bayer Germany, Accurian and International Drug Registration.

The conference is 5-6 March. There will be a Pre-conference Workshop on 4 March on 'Performance Metrics and Benchmarking an Electronic Clinical Trials' led by Ron Marks and Rebecca Kush and a Post-conference Workshop on 7 March led by DATATRAK International on "Implementing an Environment to Enhance Site Acceptance of your EDC Solutions". The website for this conference is: http://www.visioninbusiness.com/elink.taf?EventUid=100193&CatUID=3&id=12265cdi

5-8 March - DIA 14^th Annual EuroMeeting, Basel, Switzerland, CDISC Workshop scheduled by our European Contact Group Leader and new Board Member, Dr. Udo Siegmann (PAREXEL).

10-12 March 2002 - DIA meeting "Innovative Statistical Strategies in Today's Environment", Hilton Head, South Carolina. There will be a Session entitled: "The Importance of Data Standards in Statistical Analysis" This presentation will discuss recent industry advances in defining data standards for submission data, including CRTs and analysis datasets. Speakers will review the content of the current CDISC models, describe how the models are being used by industry and within the FDA, suggest how they may influence the work of statisticians and statistical programmers, and give an indication of where the standards-development activities will be heading in the future.

• The CDISC Submission Data Standards for CRT Datasets
  Wayne Kubick (BA, MBA)
  Vice President, Lincoln Technologies and Technical Director, CDISC
• The CDISC Analysis Data Models
  Dave Christiansen, Dr PH
  Consultant
  Board Member, CDISC
• The Implication of Data Standards for FDA Statisticians
  Speaker Invited from FDA (presumably Steve Wilson)

17-20 March 2002: DIA Clinical Data Management Meeting, Charleston, South Carolina. Geoff Gordon (Lincoln Technologies) will chair the CDISC session, which will include an introduction by Mr. Gordon on "Challenges Ahead: Applying the CDISC models to CDM: and presentations by Robert Zambarano (PPD Informatics) on "A Data Migration System Based upon the CDISC ODM"; Scott Getzin (Eli Lilly) on "Labs and XML: Back to Basics"; Michael Walega (Covance) on "Identifying, Testing and Implementing Data Standards at a CRO: Strategies for Success".

26-27 March 2002: Summit on Clinical Trials Management by Strategy Institute, Toronto, Canada, will include a CDISC presentation (tentatively, the speaker will be Kelly Vaillant of Pharmacia).

18-19 April 2002 -- The 2nd Conference on Software Validation for Health Care, Düsseldorf, Germany. Presentation with the title "CDIS Clinical Data Interchange Standard Consortium" by Udo Siegmann on Thursday 18 April 2002.

Further information on the conference can be found at the web site http://www.csvhc.com. There you can also register for the event. For registration by February 28, 2002 a discount of 10% will be granted!

24 April 2002 - IIR's 11^th Annual Partnerships with CROs Conference, Orlando, FL, will include a session chaired by Dr. Susan Bassion and including CDISC LAB team participants. The session will cover partnering relationships among central clinical laboratories, CROs and pharmaceutical companies, with particular reference to the activities of the CDISC LAB Team during the development of their content model.

29 April - 3 May 2002 - HL7 Working Group Meetings and Clinical Trial Special Interest Group Meetings, Sheraton Atlanta Hotel, Atlanta, GA; Online/Early Bird registration through 28 March.

American Medical Informatics Association (AMIA) Spring Congress will take place in Scottsdale, Arizona on 20-22 May. Carol Broverman and Randy Levin are on the program committee for this Congress. Wayne Kubick will be presenting on 20 May.

TEPR 2002 Annual Conference and Exhibition will be held 11-16 May in Seattle, WA. Topics include "Creating the Pathway to Electronic Health Care (TEPR)", "Mobile Applications and Technologies (Wireless)"; "Privacy, HIPAA and Beyond (Security)" and "Proven Value Propositions (Results)". Dr. Charles Jaffe will be chairing sessions on ePharma: Separating Myth from Reality (Parts I and II) and on eClinical Trials on Tuesday and Wednesday, 14 May and 15 May, respectively. Speakers for the eClinical Trials session will include Eric Hayashi (Radiant Research), Dr. Rebecca Kush (CDISC), Dr. Ronald Marks (MarCon Global Data Solutions), Dr. John Weiler (CompleWare) and Roger Stein (Fast Track Systems).

There will be an eClinical Trials Conference in German sponsored by Vision in Business, Berlin, Germany, 15-16 May. Participants will be Dr. Udo Siegmann (Parexel, CDISC), Joerg Dillert (Phase Forward), Andreas Grommen (Schering AG) and Jens Reinhold (Schering AG). Topics will include implementation experience with the CDISC SDM and ODM and cost benefits in introducing CDISC standards.

May 16, 2002-, 9:00am to 4:00pm - CDISC Education and Training Workshop CDISC Submission Data Model: Theory and Applications ,Hyatt Regency Crystal City, Ronald Reagan National Airport, Arlington VA. Reservations accepted by swilliams@cdisc.org through Friday, 3 May 2002 only.

Recognizing the continuing support of the CDISC Sponsors and Members the Board of Directors reduced the cost for this one-day training session as follows:

$1,000 for non-CDISC Members
$ 500 for CDISC Sponsors and Members
$ 250 for Government employees.

20-22 May - The 2002 Spring Congress of American Medical Informatics Association (AMIA) will be held in Scottsdale, AZ. It is entitled "A Drug By Any Other Name: The Role of Informatics in Drug Development Through the Point-of-Care". Wayne Kubick will present on CDISC on 20 May. Drs. Randy Levin, Carol Broverman and Charles Jaffe are on the Program Committee for this 2002 Spring AMIA Congress.

May 5, 2002, 8:00am-12:00pm - CDISC Laboratory Data Transmission Standard & XML Conversion Seminar, PharmaSUG 2002, Little America Hotel, Salt Lake City, UT. Cost: $95 (all tuitiion will go to the conference, a non-profit organization).To register, access http://pharmasug.org and click on "Conference."

May 6, 2002, 8:00am-9:00am - Presentation, "The CDISC Laboratory Data Interchange Standard: Using SAS to Read and Write CDISC Compliant Data Sets and Files", PharmaSUG 2002, Little America Hotel, Salt Lake City, UT. The paper outlines Covance and GSk testing on lab model (v. 12).

ACDM Lab Special Interest Group
10 October 2002
GlaxoSmithKline, Greenford
See Agenda

Clinical Data Interchange Standards Consortium (CDISC) Education and Training Opportunities
CDISC Educational Objectives

To further advance the mission of the consortium with respect to the development and dissemination of standard data models throughout the industry, CDISC has developed specialized training programs for each of the model systems. The goals of these programs are to provide training and education on the theory and practice of using the CDISC model systems and to provide the tools and information needed to implement these model systems within organizations. More info

47th Annual Conference of the German Association for Medical Informatics, Biometrics and Epidemiology 10 September 2002, Berlin, Germany "Clinical Data Management under considerations of ICH GCP and 21 CFR Part 11" by Margarete Rudloff of Kendle CDISC presentation by Udo Siegmann of Parexel For more information, see the website.

Electronic Clinical Trials System and Technology Forum Park Hyatt Philadelphia at the Bellvue Philadelphia, PA November 18-20, 2002 Capture Excellence In Clinical Trail Management Systems, EDC and Emerging Technologies to Transform Total Clinical Operations and Regulatory Compliance. http://www.melifesciences.com/cdisc.htm

DIA ePharma Enabling Clinical Research and Business in the Biopharmaceutical Industry, eTrials: Transforming Clinical Research, eBusiness: Transforming the Pharmaceutical Industry. 21-23 October 2002, Wyndham Franklin Plaza Hotel, Philadelphia, PA. See Brochure

A workshop on "Electronic Regulatory Submissions" will be sponsored by Advanstar Communications 6-7 June 2002. Wayne Kubick (Lincoln Technologies, CDISC) is on the program for this meeting, along with many of our CDISC sponsors.

16-20 June 2002 - 38^th Annual DIA Meeting, Chicago, IL. CDISC is tentatively planning another Clinical Data Connectathon or similar proof-of-concept event. Please let us know if you are interested in participating in any number of ways. There will also be a workshop on eClinical by Drs. Stephen Ruberg, Ronald Marks (MarCon) and Rebecca Kush.

Don't miss the CDISC Clinical Data Connectathon on Tuesday, 18 June, 5:30-7 p.m. at the Hilton in Chicago (in conjunction with the DIA Annual Meeting)! We now have over 30 participants who will be demonstrating how they are using the CDISC models. Although there is no dedicated CDISC session this year at the Annual DIA Conference, there are several CDISC-oriented presentations, including speakers Michael Palmer, Geoff Gordon, Dave Christiansen, Kaye Fendt and Wayne Kubick. Please look for these presentations on the program on Monday afternoon and on Tuesday and Wednesday mornings, 17-19 June.

European CDISC Kick-Off Meeting in Frankfurt, Germany, June 26th, 2002

LIMS: (Laboratory Information Management Systems) For Pharmaceutical & Life Sciences R&D 9/4/02 - 9/5/02 (Philadelphia, PA) Automating Analytical and Administrative Functions to Reduce Human Error and Ensure Streamline Processes Streamlining Laboratory Data Interchange: The CDISC Perspective Susan Bassion, LAB Team Leader, 4 September, 2:00 pm http://www.acius.net

30 September - October 4 - HL7 Working Group Meetings and Clinical Trial Special Interest Group Meetings, Wyndham Baltimore Inner Harbor, Baltimore, MD; Online/Early Bird registration through 29 August.

Pharmaceutical Education Associates presents
Leveraging XML for Pharmaceutical R&D Information Exchange
Innovative Solutions for Accelerated Data Interchange and Integration
November 18-19, 2002 at The Ritz-Carlton, Tysons Corner, McLean, VA
To register call 800-280-8440, or visit www.pharmedassociates.com

CDISC-CenterWatch Research Project Progress and Symposium
“EDC: Today’s Realities, Tomorrow’s Possibilities”

In order to provide the industry with a comprehensive understanding of the current industry attitudes, adoption, and usage of technologies and data interchange standards for electronic clinical trials, the Clinical Data Interchange Standards Consortium (CDISC) and CenterWatch conducted a research project that was sponsored by 23 industry corporations (including pharmaceutical companies, CROs, and technology providers). Other organizations who collaborated by distributing a questionnaire to their membership included the EDM Forum, the Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP), Society of Clinical Data Management (SCDM), American Association of Pharmaceutical Physicians (AAPP), the Clinical Research Roundtable, and Association of American Medical Colleges (AAMC).

The online questionnaire received responses from 750 individuals. The data are currently being summarized. An initial set was made available to sponsors on 23 October. Thank you to all who participated!

Symposium Scheduled for 21 November 2002
Webcast available 6 December

Clinical Data Interchange Standards Consortium (CDISC), CenterWatch and PPD, Inc. announce a symposium to be held on 21 November 2002. Highlights from the aforementioned CDISC-CenterWatch industry-wide research project will provide the framework for the discussion. Representatives from pharmaceutical companies, academic and for-profit clinical investigative sites, clinical research organizations and quality assurance will serve on the panel to exchange ideas on how processes are being used and issues that need to be solved to utilize EDC technologies and standards successfully across the industry.

The symposium, “EDC: Today’s Realities, Tomorrow’s Possibilities,” will be held at the BTI Center for the Performing Arts in the Kennedy Theatre in downtown Raleigh, N.C., on November 21, 2002, from 8:30 a.m. until 12:30 p.m. ET. The symposium will also be recorded and available via Webcast beginning 6 December 2002.

For more information and to register to attend the live symposium, visit www.ppdi.com/EDCSymp . The Webcast of the symposium will be available via this same site on 6 December 2002.

“EDC: Today’s Realities, Tomorrow’s Possibilities” is sponsored by an educational grant to CDISC from PPD.

18-20 November - Electronic Clinical Trials System and Technology Forum Philadelphia, Park Hyatt Philadelphia

A Marcus Evans conference is planned to focus on the theme “Capture Excellence in clinical trial management systems, EDC and emerging technologies to transform total clinical operations and regulatory compliance”. There is an all-day pre-conference workshop on EDC. Day One of the conference focuses on process and transitional changes toward an electronic format, trial management systems and cost effectiveness. The afternoon has two tracks: Clinical Operations and Business Processes and Emerging Technologies for Clinical Trials. Day Two will cover regulatory issues and compliance and standards for eClinical Trials. Wayne Kubick will be presenting “Applying CDISC Standards for eClinical Trials”, Charles Jaffe and Frank Newby will also have presentations on this program as will other CDISC sponsor representatives.

18-19 November - Leveraging XML for Pharmaceutical R&D Information Exchange Tysons Corner, McLean VA, Ritz-Carlton

Featuring a Special Presentation: Norman Stockbridge, Senior Medical Officer, CDER, FDA ‘FDA XML Standard for Exchange of Annotated ECG's’

This exclusive event addresses timely issues including:

• Why XML is the frontrunner of tools to acquire in implementing the most efficient document management method
• How XML can provide a single solution for submission authoring, publishing, and review
• Utilizing XML as a means of expediting clinical development and regulatory submissions processes and enhancing capabilities for safety surveillance
• Interacting successfully with the FDA e-review team and making the cost-benefit assessment of an FDA e-submission
• How XML fits into your organization's eCTD strategy
• An overview of the CDISC Operational Data Model
• Establishing standards for multi-system interoperability which allows data exchange between systems at the transaction level
• Making the go/no go decision to migrate existing data to XML and planning the scope of the project
  

Also, don't miss the pre-conference workshop:
"Understanding the Relationship Between XML Technology and Business Processes Across the Pharmaceutical Enterprise"
Facilitated by Jean Kaplansky, Systems Analyst, Global Document Solutions, PFIZER GLOBAL R&D
To Register call 800-280-8440 or visit
www.pharmedassociates.com
Please mention keycode PR33

5-6 December 2002 - Electronic Data Capture Barcelona, Spain, Fira Palace

This conference will focus on the use of EDC to speed the time-to-market and achieve the promise of more efficient trials.
Rebecca Kush (CDISC) and Joris Cauquil (Pierre-Fabre) will be presenting on the first day of the conference: “CDISC – Progress, Implementation and the Latest Update”. Rebecca Kush (CDISC) and Ron Marks (MarCon Global Solutions) will also be leading a pre-conference workshop on the topics of Key Metrics and Standard Definitions for Electronic Clinical Trials.

For the full program and further details, please visit the website
or contact Katie Evans at 44 (0) 20 7017 5173
(Katie.evans@informa.com)
http://www.ibc-lifesci.com/edc?src=CDISC