Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study
On July 23, 2013, FDA is conducting a public workshop on Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study. The workshop will introduce for discussion a new nonclinical paradigm for assessing Torsade de Pointes (TdP) risk and explore the parameters for an appropriate, strong, nonclinical proarrthymia screening method as an alternative to clinical Thorough QT studies.
This website will be updated as meeting materials are developed.
July 23, 2013
8:00 a.m. to 6:00 p.m
FDA White Oak Campus 10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993
To register for this meeting:
Non FDA attendees https://evm.auxserv.duke.edu/iebms/reg/reg_p1_form.aspx?oc=10&ct=DCRIHBD09&eventid=50715.
FDA attendees: https://duke.qualtrics.com/SE/?SID=SV_bmv7T8GPm4IAPd3
Registration for non FDA attendees will close on July 15, 2013.
Planned Activities: http://www.hesiglobal.org/i4a/pages/index.cfm?pageID=3620
Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2013-06-19/pdf/2013-14580.pdf