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WHO's CIOMS VI Working Group Unveils Report on Safety and Ethical Concerns in Clinical Trials

At the Clinical Trials Congress, taking place at the Loews Philadelphia Hotel from February 23-25, the CIOMS VI Working Group will reveal their report entitled "The Management of Safety Information from Clinical Trials." This highly anticipated report will be presented by Dr. Wendy Stephenson, former Senior Vice President of Global Safety Surveillance and Epidemiology at Wyeth and Co-Chair of the CIOMS Working Group.

Due to recent safety concerns surrounding Merck's decision to remove Vioxx from the market, this valuable report comes at a crucial time for the pharmaceutical industry. This compelling study aims to answer some of the public's safety concerns by addressing the following topics:

--  Managing Safety During Development Using a Systematic Approach
--  Collecting and Managing Safety Data During Clinical Trials
--  Identifying and Evaluating Risk from Clinical Trial Data
--  Using Statistical Approaches for Clinical Safety Data
--  Regulatory Reporting and Communicating Information from Clinical Trials
    

Click here for more information on the release of this report: http://www.iirusa.com/clinical/index.cfm/Link=89

Dr. Stephenson has been a member of the CIOMS Working Groups II - VI on clinical drug safety, beginning in 1990. The CIOMS Working Groups, under the auspices of the World Health Organization, have provided a forum for experts from industry, government and academia to address issues of mutual interest and concern. Published proposals often influence national legislation and industry practice. She also participated in the development of some of the International Conference on Harmonization (ICH) efficacy and safety consensus documents.

In addition to Dr. Stephenson's presentation, the Clinical Trials Congress features over 70 presenters on a three-day, multi-tracked program, including Dr. Janet Woodcock on the FDA's Critical Path Initiative. Having been deemed the industry's leading clinical event, the third annual CTC draws a crowd of over 500 and boasts a sold out exhibit hall. Featured presenters include:

Janet Woodcock, MD        Director, CDER         FDA

Ronald Krall, MD          SVP, WW Development    GLAXOSMITHKLINE

Sylva Collins, PhD        VP, Advanced
                           Clinical Systems      NOVARTIS PHARMACEUTICALS

Jim Tiede, PhD            Vice President,
                           Clin Ops              CENTOCOR

Findlay Walker, MD        VP, Clinical
                           Development           SANKYO PHARMACEUTICALS

Peter Carberry, MD        Vice President,
                           Clinical Trials       JOHNSON & JOHNSON

Rebecca Kush, PhD         President              CDISC

Robert Goodwin            Sr. Director,
                           Clin Ops Strategy     PFIZER

Jerry Schindler, DrPH     Asst VP, Biostats
                           & Clin Systems        WYETH RESEARCH

Ulo Palm, MD              Exec Director,
                           Clin Ops, Oncology    NOVARTIS

Gary M. Lubin             Co-Founder             MERCK CAPITAL VENTURES

Larry A. Blankstein, PhD  Sr Director
                           Clinical Research     GENZYME CORPORATION

Lawrence Hirsch, MD       Exec Dir, Medical
                           Communications        MERCK RESEARCH LABS

Per Cantor, MD, PhD       Global Medical
                           Director              ELI LILLY & CO.

Controversial presentations on today's hottest issues and events, including:

--  FDA's Critical Path Initiative: What Elements Relate to Clinical
    Trials and the FDA's Suggestions for Improving and Expediting Drug
    Development
--  Industry Consolidation: Case Study Presentations on the Effects of
    Mergers and Acquisitions on Clinical Trials
--  Clinical Trial Competitive Intelligence: What are the Implications for
    the Proposed Clinical Trial Registry?
--  Globally Allocating Clinical Resources: Managing Cost-Effective
    Offshore Trials while Recognizing Key Ethical Challenges
--  Full Service CRO v. Niche Provider: What is the Future of Outsourcing?
--  Globalization of Data Systems -- Strategies for Successful Systems
    Integration and Challenges of EDC Scale-up for Deployment on a Global Basis
--  Emerging Technologies -- What New Technologies are being Used in
    Clinical Trials?
    

6 DIFFERENT TRACKS AT 2005 CLINICAL TRIALS CONGRESS

1.   Patient Recruitment
2.   Clinical Technologies
3.   Strategic Partnerships and Alliance Management
4.   Contracts, Budgets and Negotiations
5.   Clinical Study Design and Management
6.   Regulations

Distributed by Market Wire