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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

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Integrated Cardiac Safety

Session Chair(s)

Norman Stockbridge, MD, PhD

Norman Stockbridge, MD, PhD

Director, Division of Cardiology and Nephrology, OND, CDER

FDA, United States

This session will discuss the evolution of cardiac safety and changes since the ICH E14 inception. Speakers will address why the TQT trial design is phasing out and discuss alternative options.

Learning Objective : Discuss the components and evolution of cardiac safety.

Speaker(s)

Joerg Seebeck, DrMed, MD

Risk of Drug-Induced QT Interval Prolongation by Monoclonal Antibody Medicines: A Review of Data From an EU Database

Joerg Seebeck, DrMed, MD

Merck, Germany

Tim Callahan, PhD

Integrated Cardiac Safety in the Post E14 Era

Tim Callahan, PhD

Biomedical Systems, United States

Chief Scientific Officer

David Strauss, MD, PhD

Clues to Proarrhythmic Potential of Drugs From the Human ECG

David Strauss, MD, PhD

FDA, United States

Director, Division of Applied Regulatory Science, OCP, OTS, CDER

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