4/11-13/2010: Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding

4/11-13/2010: Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding

Co-sponsored by the DIA, FDA, and Heart Rhythm Society; 11-13 April 2010, 9:00am to 5:00pm daily, Sheraton National Hotel, Arlington, Virginia

Overview: New directions, Practical challenges, Possible solutions, and Regulatory approaches in the Development of Pharmaceutical Agents.

This conference, co-sponsored by the FDA and Heart Rhythm Society, will bring together FDA, PMDA, academic, industry, and global regulatory speakers in an open forum. The sessions will include in-depth discussion of the evolution of drug development, cardiac QT issues, cardiovascular safety, and strategies for analyzing and mitigating potential risks to improve cardiac safety analysis during drug development. Featuring close interaction with FDA policy-makers and industry and academic experts, this has become the premier conference for keeping current in this field.

Featured Session Topics:

  • Preclinical Testing and QT/Torsade de Pointes Assessment
  • Thorough QT Study – Key Issues
  • ICH E14 Issues Under Consideration
  • CV Safety Unrelated to QT
  • Debate: Automatic QT Assessment will Replace Manual and Semi-Automatic QT Techniques for the Thorough QT Study 
  • Abstract Presentations

For more information, click here.