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

From: D'Agate, Salvatore <s.d'agate_at_ucl.ac.uk>
Date: Mon, 9 May 2016 09:45:52 +0000

Dear NMUsers,

We would like to draw your attention to the Satellite Symposium - PKPD mode=
lling of QT interval – Regulatory Perspective and impact of ongoing revis=
ion of ICH S7B and E14 guidelines, which will take place before the PAGE me=
eting.

Date: 07 June 2016, from 13:00 – 17:00.
Venue: Faculty of Pharmacy, University of Lisbon, Portugal.

Regulatory agencies, academic researchers and pharmaceutical companies appe=
ar to have recognised the drawbacks of the existing approach for the evalua=
tion of pro-arrhythmic properties based on a predominant focus on the hERG =
channel. As a result, at the conference of the Cardiac Safety Research Cons=
ortium (CSRC)-Health and Environmental Sciences Institute (HESI)-Food and D=
rug Administration (FDA) held in July 2013, a revision of ICH S7B and possi=
ble elimination of ICH-E14 was proposed. Of note is the shift from evaluati=
ng QT prolongation to evaluating pro-arrhythmic activity using a comprehens=
ive in vitro pro-arrhythmia assay (CiPA). This satellite symposium will be =
an opportunity to discuss the role of PKPD modelling and clinical trial sim=
ulations 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 throu=
gh this link<http://goo.gl/forms/NiAkF9tXtk>. The final program can be down=
loaded here<http://www.page-meeting.org/page/page2016/ProgramQTModelling.pd=
f>. For further information, contact: Salvatore D’Agate (s.d'agate_at_ucl.ac=
.uk).


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’agate_at_ucl.ac.uk


Received on Mon May 09 2016 - 05:45:52 EDT

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