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Third Cardiac Safety Workshop in Japan

 
  March 26, 2012  
     
 
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

 

 
 
Organized by: DIA Japan
Invited Speakers:
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

 
Deadline for Abstracts: N/A
 
Registration:
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
E-mail: keiko.cambridge@diajapan.org
 
   
 
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