The Drug Information Association (DIA) will host an educational forum in conjunction with the U.S. Food & Drug Administration (FDA) and the Heart Rhythm Society on QT and Arrhythmia Issues in Drug Development (April 7-8 in Bethesda, MD). The workshop will focus on the new direction in the development of pharmaceutical agents for cardiac repolarization.

Specific areas of concentration will include:

QT study design and analyses; the use of new methodologies including concentration - effect modeling; approaches to QT evaluation in Phase 3, when there is a QT signal; QT assessment in patient populations when healthy volunteers cannot be studies; QT assessment of biologic compounds; regulatory implications and a special session on the science and clinical ramifications of QT shortening.
Workshop content will be relevant to a variety of disciplines in drug development including academic scientists, industry management, clinical project physicians, quality assurance directors, preclinical/ discovery scientists, ECG safety data managers, ECG lab and equipment vendors, regulatory specialists, and safety assessment personnel.

In addition to the two-day conference, a pre-event tutorial: An Introduction to QT Issues in Drug Development will be offered on April

The tutorial will provide attendees with the resources and information necessary to understand relevant concepts in the collection, analysis, and interpretation of ECG parameters in their own clinical trials and to learn of the most recent developments in clinical interpretation of QT/QTc prolongation.

For more information, contact Joanne Wallace at 215-442-6180 or
Joanne.Wallace(at)diahome.org. Media interested in attending the event or arranging for pre- or post-event interviews should contact Joe Krasowski at 215-293-5812 or Joe.Krasowski(at)diahome.org.