DIA Japan Cardiac Safety Workshop Ushers in New Age of Drug Approval

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DIA, the premier global organization dedicated to knowledge exchange that fosters innovation to raise the level of health and well-being worldwide will host the 3rd Cardiac Safety Workshop in Tokyo, Japan. Although Japan’s experience in conducting and analyzing the Thorough QT Study (TQTS) is rapidly advancing, issues remain.

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“While experience in conducting and analyzing TQT studies in Japan is rapidly developing, some issues remain. This workshop will address and help you to overcome these issues.

DIA, the premier global organization dedicated to knowledge exchange that fosters innovation to raise the level of health and well-being worldwide will host the 3rd Cardiac Safety Workshop in Tokyo, Japan. Although Japan’s experience in conducting and analyzing the Thorough QT Study (TQTS) is rapidly advancing, issues remain.

This workshop will discuss topics related to:

  •     Satisfying the ICH-E14 guidance
  •     TQTS or its alternatives for certain drugs
  •     Ethnic differences in QT pharmacodynamics
  •     Extrapolation of QT data from foreign studies into Japanese subjects
  •     Positive control, advanced study designs, and methods for concentration (effect modeling)

“Currently, pharmaceutical companies applying for new drug approval in Japan are now required to satisfy the International Conference on Harmonisation (ICH) E14 Guidance. The hallmark of the ICH-E14 guidance is the Thorough QT Study (TQTS) or its alternatives for drugs that do not lend themselves to the E14 TQTS paradigm,” says Program Chair Boaz Mendzelevski, MD, CoreLab Partners, Inc., UK. “While experience in conducting and analyzing TQT studies in Japan is rapidly developing, some issues remain. This workshop will address and help you to overcome these issues.”

Register today for the 3rd Cardiac Safety Workshop.

ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. http://www.diahome.org.

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第3回DIA カーディアック・セイフティ・ワークショップ

Contacts: Joe Krasowski
DIA
+1-215-293-5812

Christine Tarlecki
DIA
+1-215-442-6154

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Christine Tarlecki

Joe Krasowski
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