ICH-E14 guidance was finalized in May 2005. An important component of the guidance is the requirement of the Thorough QT Trial (TQT) in the development of new drug candidates. In this presentation, Dr. Joel Morganroth will provide "up-to-the-minute" insights into the ICH guidance and practical implications for implementation of the TQT.
Chicago, IL (PRWEB) May 18, 2007 -- Xtalks and eResearchTechnology are pleased to present the web conference ICH-E14 Two Years Later -- Trends in Design & Conduct of a thorough ECG Trial (TET), scheduled for May 31, 2007.
ICH-E14 guidance was finalized in May 2005. An important component of the guidance is the requirement of the Thorough QT Trial (TQT) in the development of new drug candidates.
The presentation will detail what has been learned in the first 90 TQTs, which may influence future study design and statistical approaches for such trials.
Dr. Joel Morganroth will provide "up-to-the-minute" insights into the ICH guidance and practical implications for implementation of the TQT. Comprehensive insight into emerging trends in TQT design, conduct and data analysis will be discussed in addition to the provision of an overview of the structure and function of the QTc Interdisciplinary Review Team of the FDA.
There is no cost to attend, register at: http://www.xtalks.com/ecgtrials.ashx
Pre-web Cast Questions
How does the ICH E14 guidance define which new drugs require a TQT before starting Phase III?
What has been learned about study design and analysis of Thorough QTc Trials over the past two years?
What technical and logistical requirements are required to conduct successful Thorough QTc Trials?
The ICH-E14 Two Years Later -- Trends in Design & Conduct of a thorough ECG Trial (TET) web conference takes place May 31, 2007, from 11:00 a.m. - 1:00 p.m. EDT.
Register at: http://www.xtalks.com/ecgtrials.ashx
Joel Morganroth, M.D., F.A.C.C., Chairman, Chief Scientist, eResearchTechnology, Inc.
Joel Morganroth, M.D. has an international reputation as a cardiovascular drug development specialist. Dr. Morganroth's experience includes memberships on Data Safety and Monitoring Boards for the National Institutes of Health and the Veterans Administration research programs and several major Pharmaceutical trials. He has published over 300 articles and edited nearly two dozen books and is frequently invited to lecture on a variety of cardiac and clinical research regulatory issues.
About eResearchTechnology:
eResearchTechnology (eRT) provides technology and services that enable life sciences industries to collect, interpret and distribute cardiac data accurately and efficiently. eRT is a leading provider of centralized electrocardiographic (ECG) services and supports the full-range of studies from single center to multi-center global trials across all therapeutic groups. eRT is an industry leader for Thorough QTc Trials (TQT), having completed significantly more than any other core lab. www.ertECG.com
About Xtalks
Xtalks is part of The Honeycomb Worldwide Group of Companies. Honeycomb Worldwide creates peer-to-peer business-oriented social networking communities, connecting senior level executives by delivering content through new and established media channels and is currently ranked 15th on the Profit Hot 50 List of emerging Canadian companies. www.honeycombworldwide.com.
For more information on this conference or Xtalks in general, or to enquire about speaking opportunities or sponsoring future events, visit www.xtalks.com or contact Karen Anderson, Chief Marketing Officer, at phone: 312-977-1166, x. 1209.
Register at http://www.xtalks.com/ecgtrials.ashx
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Press Contact: KAREN ANDERSON
Company Name: Xtalks
Phone: 312-977-1166
Website: http://www.xtalks.com/ecgtrials.ashx
