Speakers: Borje Darpo, MD, PhD, iCardiac Technologies
Registration deadline:1/27/2017 (it will close sooner if the seating cap is reached)
About the Topic
Based on extensive experience with exposure response analysis of ECG data and the IQ-CSRC validation study, ICH 14 has been revised and now allows the thorough QT (TQT) study to be replaced by robust ECG monitoring and exposure-response (ER) analysis of data generated from First-in-Man studies. This seminar will discuss the IQ-CSRC study, requirements for Early QT assessment, share examples of successful TQT study waivers and give an update on recent regulatory discussions on studies using exposure analysis.
Who should attend:
Those working in academia and industry, pharmaceutical research and development, clinical development, regulatory affairs, and drug safety in general.