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Vancouver PBSS Early Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential: A Pharmaceutical Industry Perspective

February 3, 2017 | 11:00 am CDT - 1:30 pm CDT

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Seminar Luncheon: 
Early Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential: A Pharmaceutical Industry Perspective

Speakers: Borje Darpo, MD, PhD, iCardiac Technologies
Time: 11:00-13:30
Registration: http://www.PBSS.org
Registration deadline:1/27/2017  (it will close sooner if the seating cap is reached)

About the Topic

Based on extensive experience with exposure response analysis of ECG data and the IQ-CSRC validation study, ICH 14 has been revised and now allows the thorough QT (TQT) study to be replaced by robust ECG monitoring and exposure-response (ER) analysis of data generated from First-in-Man studies. This seminar will discuss the IQ-CSRC study, requirements for Early QT assessment, share examples of successful TQT study waivers and give an update on recent regulatory discussions on studies using exposure analysis.

Who should attend:

Those working in academia and industry, pharmaceutical research and development, clinical development, regulatory affairs, and drug safety in general.

Details

Date:
February 3, 2017
Time:
11:00 am CDT - 1:30 pm CDT
Website:
https://www.pbss.org/aspx/eventInfo.aspx?eID=526

Organizer

Vancouver Pharmeceutical & Bioscience Society
Website:
https://www.pbss.org/pbsindex.html

Venue

The Floral Hall at VanDusen Gardens
5251 Oak St
Vancouver, British Columbia BC V6M 4H1 Canada
Website:
http://vancouver.ca/parks-recreation-culture/vandusen-botanical-garden.aspx