The 1st DIA Cardiac Safety Workshop in Japan

Venue: Tower Hall Funabori

Location: Tokyo, Japan

Event Date/Time: May 25, 2010 End Date/Time: May 25, 2010
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Recent, high-profile, drug-related cardiac adverse eff ects triggered public
and regulatory concerns which resulted in the development of new cardiac safety regulatory guidance. The ICH-E14 Guidance was fi nalized in May 2005 and was first implemented in the US and Europe. In October 2009 the MHLW officially published notification for the implementation of theICH-E14 in Japan. While the MHLW E14 version is effectively the same as
those released by FDA and EMEA, variations in interpretation are possible. However, questions such as the predictive value of nonclinical assays,ethnic differences in drug exposure and QT/QTc effects, possible need for
extrapolation of foreign QT data, conditions for acceptance of overseas Thorough QT (TQT) study data for marketing approval in Japan, design and execution of TQT studies in Japan and the use of positive control in TQT studies performed in Japan, remain open.

At the same time global experience with TQT study design, performance,analysis, and interpretation are improving, and sample size is dropping. In addition, experience with the assessment of cardiovascular safety in
therapeutic areas previously exempted from QT scrutiny, such as oncology and biological agents, is now developing.

This DIA workshop will provide the first opportunity for an open public
discussion of the implementation of ICH-E14 guidance in Japan. A panel of academic, industry, and regulatory experts will review and discuss some of the ongoing and unresolved issues and provide opportunities for interactive involvement with the audience.