Date: 7th June 2016Time: 13:30 – 17:30 hVenue: Auditorium of the Faculty of Pharmacy, University of Lisbon.
13:30 – 13:55 h - QTc prolongation and characterisation of torsadogenic effects of drug candidatesSpeaker: Derek Leishman, Eli Lilly, USA
13:55 – 14:25 h – Overview of the ICH E14 guideline – perspectives from industrySpeaker: Charles Benson, Eli Lilly, USA
14:25 – 14:55 h - Overview of the ICH E14 guideline and scientific rationale for using C-QTc modelling as primary analysis Speaker: Jiang Liu, CDER, FDA, USA
14:55 -15:25 h - Modelling the C-QTc relationship with Case Examples (1)—Technical Discussion of Model, Model Selection, Goodness-of-fit, and Model PredictionsSpeaker: Anne S Chain, Merck, USA
15:25 -15:50 h - Coffee break
15:50 – 16:15 h - Modelling the C-QTc relationship with Case Examples (2)—Technical Discussion of Model, Model Selection, Goodness-of-fit, and Model Predictions Speaker: Georg Ferber, Statistik Georg Ferber GmbH, Switzerland
16:15 -16:45 h - Regulatory evaluation of CQTc modelling results Speaker: Flora Musuamba, Modelling & Simulation Working Group, EMA, UK
16:45 -17:20 h - Round tableAll speakers
17:20 -17:30 h - Wrap-up and closure
Registration is free of charge. However, contact the organising committee as soon as possible to cancel your enrolment if you are not able to attend the event.