Title:
The 1st DIA Cardiac Safety Workshop in Japan
Date(s) And Time(s):
May 25 2010 9:00AM - May 26 2010 5:05PM
Location:
Tower Hall Funabori
4-1-1 Funabori
Edogawa-ku
Tokyo
134-0091 Japan
Overview:
Recent, high-profi le, 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 fi rst implemented in the US and Europe. In October 2009
the MHLW offi cially published notifi cation for the implementation of the
ICH-E14 in Japan. While the MHLW E14 version is eff ectively 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 diff erences in drug exposure and QT/QTc eff ects, 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 fi rst 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.
CONFERENCE THEMES
• Implementation of ICH-E14 Cardiac Safety Guidance in Japan
• Strategies for Early Development of Cardiac Safety Database
• Cardiac Safety Biomarkers for Drug-induced Arrhythmia
• Predictive Value of Nonclinical QT/Arrhythmia Assays
• Statistical Methods for Analysis of Thorough QT Data
• Future Trends of Regulatory Review for Cardiac Risk Assessment
Learning Objectives:
CONFERENCE OBJECTIVES
• Stay abreast of emerging trends in cardiac safety risk assessment
• Review evidence for predictive value of nonclinical and clinical QT assays
• Determine emerging paradigms and methods for QT analysis and reporting
• Learn of novel cardiac risk assessment and risk management methods
• Discuss the impact of requirements on drug development strategies
• Novel biomarkers for detection of drug-induced arrhythmia risk
Target Audience:
• Drug development and clinical research managers and associates
• Pharmaceutical physicians and medical directors
• Safety pharmacology and nonclinical scientists
• Drug safety and drug surveillance personnel
• Clinical pharmacology scientists
• Pharmacovigilance managers
• Regulatory aff airs managers
• Biostatisticians
• Data managers
• IT/technology managers
• Outsourcing and marketing managers
• Decision makers in cardiac drug safety, including toxicology, pharmacology and compliance
Event Code:
10305
Contact Information:
For information contact Drug Information Association, LLC
Maruei Building 4F, 2-19-9 Iwamoto-cho, Chiyoda-ku, Tokyo 101-0032 Japan
Tel: 81-3-5833-8444 Fax: 81-3-5820-8448
Email: diajapan@diajapan.org
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Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
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10305
1st DIA Cardiac Safety Workshop in Japan
Fee:
2,300 x 1,400 mm booth space................................¥157,500*
NOTE: *fee includes 5% Japanese Consumption Tax
Booth Rental Fee includes (per 2,300mm x 1,400m booth space):
• One (1) complimentary full-meeting registration;
• One (1) complimentary exhibit booth personnel registration;
• One (1) 1,800 x 600 mm table;
• One (1) chairs;
• One (1) 5A electrical connection
• Internet access
No pre-fitted shell-scheme or pipe-and-drape structure is provided.
Additional expenses associated with the exhibit, including special booths, drayage, lights, phone, carpeting, additional electrical connections, etc., will be the responsibility of the exhibitor. Additional Exhibit Booth Personnel will be allowed for ¥12,600 each (limit of 3 per booth space) - please use the Additional Exhibit Booth Personnel Registration Form under Useful Links to register additional staff.
Exhibits Show Dates:
May 25-26, 2010
Tower Hall Funabori
Tokyo, JAPAN
DIA Exhibits Contact Information:
Japanese Office:
Keiko Cambridge • Program Manager
+81-3-5833-8444 • Keiko.Cambridge@diajapan.org
US Office (Support):
Jeff Korn • Worldwide Exhibits Associate
+1-215-442-6184 • Jeff.Korn@diahome.org
Useful Links:
~ Application & Contract for Exhibit Space
~ Exhibit Personnel Registration Form
~ ADDITIONAL Exhibit Booth Personnel Registration Form (limit 3 per booth space; cancellations receive NO refund)
Exhibiting Companies:
 | Cardiocore |
| MD ,
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| ERT |
| NJ ,
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| Ina Research Inc. |
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| Quintiles Transnational Japan K K |
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| Richmond Pharmacology |
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| Site Support Institute Co., Ltd. |
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| Suzuken Co., Ltd. |
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There are a limited number of rooms at the Hotel Grand Palace at the reduced rates shown below. Room availability at this rate is guaranteed
only until APRIL 24, 2010 or until the room block is filled. Attendees should make their airline and room reservations as soon as
possible.
Single ¥ 18,050/night / Twin ¥21,525/night
Address: 1-1-1 Iidabashi, Chiyoda-ku, Tokyo 102-0072, Japan
Telephone: +81-(0)3-3264-3078 / Fax: +81-(0)3-3230-6822
email: toru-ishikawa@grandpalace.co.jp
URL: http://www.grandpalace.co.jp/english
To reserve your room, please contact the Hotel Grand Palace above and mention the DIA Workshop or click here for the Hotel Reservation Form.
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Meeting
| Member Standard | ¥64000.00 | | NonMember Standard | ¥79000.00 | | Charitable Nonprofit/Academia Member | ¥25000.00 | | Charitable Nonprofit/Academia Nonmember | ¥40000.00 | | Member Government | ¥25000.00 | | NonMember Government | ¥40000.00 |
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