Tower Hall Funabori , Tokyo, Japan
May 28 2012 9:30AM - May 29 2012 3:30PM
Pharmaceutical companies applying for new drug approval in Japan are now required to satisfy the ICH-E14 guideline. The hallmark of the ICH-E14 guidance is the Thorough QT (TQT) Study, or its alternatives for drugs that do not lend themselves to the E14 TQT paradigm. While experience in conducting and analyzing TQT studies in Japan is rapidly developing, many issues remain open. Some of these issues include the potential for ethnic differences in QT pharmacodynamics, the need to extrapolate QT data from foreign studies into Japanese subjects, the use of positive control, advanced study designs and methods for concentration - effect modelling, etc. The 3rd Cardiac Safety Workshop in Japan will explore these topics and others, including those listed in the program. Event Code: 12305
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Invited Speakers:
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PROGRAM CHAIRPERSON Boaz Mendzelevski, MD CoreLab Partners, Inc., UK PROGRAM SUB-CHAIRPERSON Maki Ito, MD, PhD Shionogi & Co., Ltd., Japan PROGRAM COMMITTEE Yasuhiko Imai Bristol-Myers K.K., Japan Yuji Kumagai, MD, PhD Kitasato University East Hospital Kitasato University, Japan Koki Nakamura, MD, PhD Takeda Pharmaceutical Company Limited, Japan Kaori Shinagawa, MD, PhD Pharmaceuticals and Medical Devices Agency (PMDA), Japan Atsushi Sugiyama, MD, PhD Toho University, Japan PROGRAM ADVISOR Yoshiaki Uyama, PhD Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Registration:
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Register online or forward to DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japan tel +81-3-5575-2130 • fax +81-3-3583-1200
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