Satellite Symposium - PKPD modelling of QT interval – Regulatory Perspective and impact of ongoing revision of ICH S7B and E14 guidelines - LAST WEEK TO REGISTER!!!

Dear NMUsers, We would like to draw your attention to the Satellite Symposium - PKPD modelling of QT interval – Regulatory Perspective and impact of ongoing revision of ICH S7B and E14 guidelines, which will take place before the PAGE meeting. Date: 07 June 2016, from 13:00 – 17:00. Venue: Faculty of Pharmacy, University of Lisbon, Portugal. Regulatory agencies, academic researchers and pharmaceutical companies appear to have recognised the drawbacks of the existing approach for the evaluation of pro-arrhythmic properties based on a predominant focus on the hERG channel. As a result, at the conference of the Cardiac Safety Research Consortium (CSRC)-Health and Environmental Sciences Institute (HESI)-Food and Drug Administration (FDA) held in July 2013, a revision of ICH S7B and possible elimination of ICH-E14 was proposed. Of note is the shift from evaluating QT prolongation to evaluating pro-arrhythmic activity using a comprehensive in vitro pro-arrhythmia assay (CiPA). This satellite symposium will be an opportunity to discuss the role of PKPD modelling and clinical trial simulations to characterise pro-arrhythmic risk and QT interval prolongation. Details of the final programme will be released soon. Participation will be free of charge, but registration is required due to limited venue capacity. Only a few seats are still available. Registration can be completed through this http://goo.gl/forms/NiAkF9tXtk. The final program can be downloaded http://www.page-meeting.org/page/page2016/ProgramQTModelling.pdf. For further information, contact: Salvatore D’Agate (s.d'[email protected]). Best regards, Salvatore D’Agate Clinical Pharmacology & Therapeutics School of Life and Medical Sciences University College London Tel.: 020 7874 1503 E-mail: s.d’[email protected]