| Wednesday, June 3, 2009 |
| 08:00:00 |
Conference registration and morning coffee |
|
| 08:30:00 |
Opening remarks from the Chairperson |
|
| 08:35:00 |
Conclusions from a review of ICH S7 guidelines |
Gerd Bode
|
| 09:05:00 |
Overview of recent Q&A with E14 working group and the impacts for your future trial designs |
Charles T Benson
|
| 09:35:00 |
Regulations Q&A |
|
| 09:45:00 |
Effectively predicting QT prolongation in humans |
|
| 10:20:00 |
Morning coffee |
|
| 11:00:00 |
The translatability of existing and emerging preclinical cardiotoxicity assays |
Matthew J Killeen
|
| 11:35:00 |
Stem cells as a tool in preclinical testing for QT prolongation |
Martin Traebert
|
| 12:10:00 |
Spotlight session |
|
| 12:45:00 |
Lunch |
|
| 14:15:00 |
Bridging the gap between non-clinical and clinical studies |
Wilhelm Haverkamp
|
| 14:50:00 |
Drug induced QT/QTc prolongation - Review of one-stage vs. two-stage methods to analyse clinical ECG data |
Jianguo Li
|
| 15:25:00 |
Afternoon tea and high speed networking |
|
| 16:05:00 |
Designing a tQT study for limited resources |
Arne Ring
|
| 16:40:00 |
Methods for reducing variability in QT assessment |
Henry Holzgrefe
|
| 17:15:00 |
Applications of mixed models in tQT studies |
Dennis Chanter
|
| 17:50:00 |
Closing remarks from the Chairperson |
|
| 17:55:00 |
End of day one |
|
| Thursday, June 4, 2009 |
| 08:30:00 |
Opening remarks from the Chairperson |
|
| 08:35:00 |
Assessing the risk of proarrythmia? |
Danshi Li
|
| 09:10:00 |
Three years post E14 guidance – Challenges and potential solutions |
Sasha Latypova
|
| 09:45:00 |
Cardiac safety strategies for FIM studies for biopharmaceuticals |
Alexander Breidenbach
|
| 10:20:00 |
Morning coffee and "meet the author" poster session |
|
| 11:00:00 |
QT study design for oncology drugs |
Corina-Dana Dota,
|
| 11:30:00 |
Unwanted QT problems in oncology programmes - A hERG trafficking case study |
Bérengère Dumotier
|
| 12:00:00 |
Q&A session - What have we learned from oncology QT studies to date? |
|
| 12:10:00 |
Spotlight session |
|
| 12:45:00 |
Lunch |
|
| 14:10:00 |
Drug related change in the ECG - A novel biomarker for cardiac risk? |
Christer Gottfridsson
|
| 14:45:00 |
Optimized Holter extractions in tQT studies |
Fabio Badilini
|
| 15:20:00 |
Afternoon tea |
|
| 15:50:00 |
Increasing power through developing technologies - 12 lead ECG to continuous recording methods |
Corina-Dana Dota,
|
| 16:25:00 |
Assessing the risk of Na channel inhibition |
Danshi Li
|
| 17:00:00 |
Closing remarks from the Chairperson |
|
| 17:10:00 |
End of conference |
|
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