Satellite Symposium on the PKPD modelling of QT interval prolongation:
Regulatory perspective and impact of ongoing revision of ICH S7B and E14 guidelines.
Date: 7th June 2016
Time: 13:30 – 17:30 h
Venue: Auditorium of the Faculty of Pharmacy, University of Lisbon.
13:15 – 13:30 h - Welcome and introduction by the chairs
Chairs: Oscar Della Pasqua and Vincent Dubois
13:30 – 13:55 h - QTc prolongation and characterisation of torsadogenic effects of drug candidates
Speaker: Derek Leishman, Eli Lilly, USA
13:55 – 14:25 h – Overview of the ICH E14 guideline – perspectives from industry
Speaker: 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 Predictions
Speaker: 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 table
17:20 -17:30 h - Wrap-up and closure
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