March 19, 2009 - The Drug Information Association (DIA), in cooperation with the Heart Rhythm Society (HRS) and the FDA, will host Cardiovascular Safety and QT/Arrhythmia Assessment in Drug Development: Optimizing Drug Development Wednesday, April 29 – Friday, May 1 in Bethesda, MD.
Regulatory, industry, and scientific leaders from around the world will convene to discuss the evolution of drug development, cardiac repolarization, and cardiovascular (CV) safety. The conference will present basic concepts related to the collection, analysis, and interpretation of clinical ECG data, taking into consideration the effect of study design and conduct on these parameters. Sessions will also cover strategies to design a program for QT assessment in all stages of clinical trials and best practices for designing, conducting, analyzing, and interpreting data from a thorough QT/QTc study.
Speakers will also address the strategy behind choosing the optimal timing of the thorough QT study, underlying regulatory thinking in terms of QT prolongation and patient safety, relevant clinical, technological, and statistical issues in the assessment of QT/QTc prolongation in clinical trials. The conference will also address emerging concepts and technologies for QT assessment, such as highly automated measurement methods and their potential role.
"This open forum will discuss the new direction in the development of pharmaceutical agents, practical challenges and possible solutions, ways of challenging the current science, and regulatory approaches,” explains Program Chair Philip Sager, M.D., FACC, FHRS, chief medical officer, CardioDx Inc.
DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and Webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
For more information: www.diahome.org