Web Conference Covers Cardiac Safety in Drug Development

 

May 30, 2007

May 30, 2007 -- Xtalks and eResearchTechnology will present a Web conference titled, "Best Practices in Cardiac Safety Data Collection Before and After the Thorough QT Trial," on June 7, 10 a.m. to noon, EDT.

Focus on cardiac safety in new drug development has increased dramatically in recent years. ICH E14 guidance was finalized in May 2005, and an important component of the guidance is the requirement of the Thorough QT Trial (TQT) in the development of new drug candidates.

Dr. Jeffrey Litwin will provide current insights into the differences between Phase I versus Phases II-III and Phase IV cardiac safety testing. He will address common ECG collection practices at sites versus best practices and when one approach may be preferred over another. Dr. Litwin will address the impact of the TQT on Phase III programs and provide additional discussion on ECG data considerations beyond QTc. Dr. Litwin will address how implementation of best practices ensures data quality and consistency and reduces data evaluation time.

The Web cast will address:
-- What is the difference between cardiac safety assessments in Phase I versus Phase II-III and Phase IV?

-- When and how many ECGs should be acquired and how should ECG measurements and interpretations be conducted?

-- How should ECGs be acquired at clinical sites and what is the role of local interpretation of ECG data?

-- How should ECG data be analyzed?

To register for the free conference visit http://www.xtalks.com/csdata.ashx, or for more information visit www.xtalks.com

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