Can QT Assessment in Early Clinical Development be used to replace the TQT Study – Presenting Results from the Prospective IQ-CSRC Clinical Study

7:30-8:00am- Registration and Continental Breakfast

8:00-9:20am- Session 1: The context and the concept of ‘Early ECG assessment’

Session chair and moderator: Borje Darpo

9:45-12:15pm- Session 2: Results and interpretations of the study

Session chair: Nenad Sarapa

1:30-3:30pm- Session 3: Clinical and regulatory implications of the study

Session chair and moderator: Christine Garnett

Panel discussion on clinical and regulatory implications of study results with presenters and invited panelists.

Moderator: Borje Darpo

  • James Keirns, Astellas
  • Dan Bloomfield, Merck
  • Philip Sager, Stanford University/Sager Consulting Experts
  • Charles Benson, Eli Lilly
  • Corina Dota, AstraZeneca
  • Kaori Shinagawa, PMDA,
  • Colette Strnadova, Health Canada,
  • Norman Stockbridge, FDA
  • Bob Temple, FDA
  • Doug Throckmorton, FDA
  • Krishna Prasad, MHRA
  • Christine Garnett (ex-E14), Certara

4:00-5:00pm- Session 4: Next steps

Session chair and moderator: James Keirns