4th Cardiac Safety Workshop in Japan

Overview

Simultaneous Translation Available

Drug effect on the cardiac repolarization and the potential for drug induced arrhythmia has long been recognized as a public health issue. In November 2010 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) ratified the ICH-E14 guidance in Japan. In compliance with the ICH-E14 requirements, a Thorough QT (TQT) Study, or an alternative QT assessment program, must be provided in support of nearly all New Drug Applications (NDA) in Japan. The science of designing, conducting and analysing TQT studies and the experience of unning these programs in Japan are rapidly evolving.

In addition, the recognition that cardiotoxicity of new drugs may involve other cardiovascular (CV) targets and mechanisms, have led to clinical and regulatory focus on specific drug classes and therapeutic areas associated with CV toxicity, including oncology, rheumatology, endocrinology and metabolism, etc. New regulations have been introduced in some major regulatory jurisdictions to assess and mitigate such adverse cardiac drug effects.

The 4th Cardiac Safety Workshop in Japan will provide an interactive platform to discuss the above and similar topics. The program committee is inviting authors to submit abstracts for review, for oral presentation at the workshop.

Hotel & Travel

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 June 9, 2013 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/index.html
To reserve your room, please contact the Hotel Grand Palace above and mention the DIA Workshop or click here for the Hotel Reservation Form.

Contact Information

Questions?
Keiko Cambridge, Program Manager
Phone +81 3.5575.2130
Fax +81 3.3583.1200
keiko.cambridge@diajapan.org

Tabletop Opportunity Available

Program Committee

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Program Committee 1-3 of 8

Koki Nakamura, MD,PhD

Senior Director, Global Medical Affairs-Japan, Takeda Development Center Japan
Takeda Pharmaceutical Company Limited, Japan

Boaz Mendzelevski, MD

Vice President of Cardiology
BioClinica Inc., United Kingdom

Hiroyuki Fukase, MD,PhD

Director, SNBL CSEC
SNBL CSEC, Japan

Program Committee 4-6 of 8

Zhe Jin, MD,PhD

Pharmacovigilance Department
Taiho Pharmaceutical Co., Ltd., Japan

Yuji Kumagai, MD,PhD

Director, Clinical Trial Center
Kitasato University East Hospital, Japan

Kaori Shinagawa, MD,PhD

Senior Scientist for Clinical Medicine
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Program Committee 7-8 of 8

Atsushi Sugiyama, MD,PhD

Chairman & Professor of Pharmacology
Toho University School of Medicine, Japan

Yoshiaki Uyama, PhD

Director, Review Planning Division, Office of Review Management
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Agenda

Day 1 Thursday, July 11, 2013

9:00AM - 9:10AM
Opening Remarks
Speaker(s):
- Koki Nakamura, MD,PhD
  Senior Director, Global Medical Affairs-Japan, Takeda Development Center Japan
  Takeda Pharmaceutical Company Limited, Japan
9:10AM - 9:40AM
Session 1: Keynote Presentation

Session Chair(s):
- Koki Nakamura, MD,PhD
  Senior Director, Global Medical Affairs-Japan, Takeda Development Center Japan
  Takeda Pharmaceutical Company Limited, Japan
Speaker(s):
- Yuji Kumagai, MD,PhD
  Director, Clinical Trial Center
  Kitasato University East Hospital, Japan
9:40AM - 12:20PM
Session 2: Global Regulatory Update

Session Chair(s):
- Kaori Shinagawa, MD,PhD
  Senior Scientist for Clinical Medicine
  Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Colette Strnadova, PhD
  Senior Scientific Advisor
  Health Canada, Canada
Speaker(s):
- Colette Strnadova, PhD
  Senior Scientific Advisor
  Health Canada, Canada
- Krishna Prasad, MD,FRCP
  Clinical Assessor/Consultant Cardiologist
  Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
- Karen Hicks
  Medical Officer, Division of Cardiovascular and Renal Products
  FDA, United States
- Börje C. Darpö, MD,PhD
  Associate Professor of Cardiology, Pharmaceutical Consultant
  iCardiac, Sweden
- Kiyoshi Nobori
  Reviewer, Office of New Drug II
  Pharmaceuticals and Medical Devices Agency (PMDA), Japan
1:30PM - 2:30PM
Sesson 3: Abstract Session

Session Chair(s):
- Yuji Kumagai, MD,PhD
  Director, Clinical Trial Center
  Kitasato University East Hospital, Japan
- Boaz Mendzelevski, MD
  Vice President of Cardiology
  BioClinica Inc., United Kingdom
Speaker(s):
- Boaz Mendzelevski, MD
  Vice President of Cardiology
  BioClinica Inc., United Kingdom
- Börje C. Darpö, MD,PhD
  Associate Professor of Cardiology, Pharmaceutical Consultant
  iCardiac, Sweden
- Snehal N Kothari, MD,FACC
  Senior Medical Director
  Quintiles Cardiac Safety Services, Mumbai, India, India
- Joerg Taubel, MD,FFPM
  Chief Executive Officer
  Richmond Pharmacology Ltd., United Kingdom
2:30PM - 5:15PM
Sesson 4: Experience in Pharmaceutical Companies

Session Chair(s):
- Koki Nakamura, MD,PhD
  Senior Director, Global Medical Affairs-Japan, Takeda Development Center Japan
  Takeda Pharmaceutical Company Limited, Japan
- Kaori Shinagawa, MD,PhD
  Senior Scientist for Clinical Medicine
  Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker(s):
- Masako Nakano, MD,PhD
  Senior Medical Advisor
  Eli Lilly Japan K.K., Japan
- Shingo Tanaka
  Clinical Pharmacology
  Takeda Pharmaceutical Company Limited, Japan
- Koki Nakamura, MD,PhD
  Senior Director, Global Medical Affairs-Japan, Takeda Development Center Japan
  Takeda Pharmaceutical Company Limited, Japan
- Pierre J Jordaan, MD
  TM Expert CardioVascular Profiling
  Novartis Pharma AG, Switzerland
- Yoshitaka Isaka, PhD
  Japan Senior Research Scientist, Clinical Pharmacology Medical
  Eli Lilly Japan K.K., Japan
- Zhe Jin, MD,PhD
  Pharmacovigilance Department
  Taiho Pharmaceutical Co., Ltd., Japan

Day 2 Friday, July 12, 2013

8:40AM - 10:30AM
Session 5: Translational Medicine

Session Chair(s):
- Hiroyuki Fukase, MD,PhD
  Director, SNBL CSEC
  SNBL CSEC, Japan
- Atsushi Sugiyama, MD,PhD
  Chairman & Professor of Pharmacology
  Toho University School of Medicine, Japan
Speaker(s):
- Hiroyuki Fukase, MD,PhD
  Director, SNBL CSEC
  SNBL CSEC, Japan
- Keiji Yamamoto, DVM,PhD,MBA
  Director, Japan Drug Safety Research Laboratories
  Takeda Pharmaceutical Company Limited, Japan
- Koh Ono, PhD
  Department of Cardiovascular Medicine
  Kyoto Universiry Graduate School of Medicine, Japan
- Atsushi Sugiyama, MD,PhD
  Chairman & Professor of Pharmacology
  Toho University School of Medicine, Japan
11:00AM - 1:00PM
Session 6: Blood Pressure as CV Safety Endpoint

Session Chair(s):
- Hiroyuki Fukase, MD,PhD
  Director, SNBL CSEC
  SNBL CSEC, Japan
- Boaz Mendzelevski, MD
  Vice President of Cardiology
  BioClinica Inc., United Kingdom
Speaker(s):
- Shinichiro Ueda, PhD
  Professor, Graduate School of Medicine
  University of the Ryukyus, Japan
- Masaki Mogi, MD,PhD
  Associate Professor, Dept of Molecular Cardiovascular Biology & Pharmacology
  Ehime Univeristy Graduate School of Medicine, Japan
- Jeffrey Heilbraun, MS
  Director Strategic Development
  Bioclinica Inc, United States
- Rajnikanth Madabushi, PhD
  Team Leader, Division of Clinical Pharmacology I, OCP, OTS, CDER
  FDA, United States
2:00PM - 4:00PM
Session 7: Cardio-oncology

Session Chair(s):
- Zhe Jin, MD,PhD
  Pharmacovigilance Department
  Taiho Pharmaceutical Co., Ltd., Japan
- Atsushi Sugiyama, MD,PhD
  Chairman & Professor of Pharmacology
  Toho University School of Medicine, Japan
Speaker(s):
- Mitsuhiro Fukata, MD
  Dept of Medicine and Biosystemic Science
  Kyushu University Graduate School of Medical Sciences, Japan
- Boaz Mendzelevski, MD
  Vice President of Cardiology
  BioClinica Inc., United Kingdom
- Yuichi Ando, MD,PhD
  Professor, Dept of Clinical Oncology and Chemotherapy
  Nagoya University Hospital, Japan
- Shyh-Yuh Liou, PhD
  Director, Clinical Pharmacology, Clinical Data Science Dept. Japan Development C
  Takeda Pharmaceutical Company Limited, Japan
4:00PM - 4:10PM
Closing Remarks
Speaker(s):
- Boaz Mendzelevski, MD
  Vice President of Cardiology
  BioClinica Inc., United Kingdom

Exhibits

The 4th Cardiac Safety Workshop in Japan offers interested companies the opportunity to exhibit with a tabletop display.

Fee:
2,300 x 2,000 mm booth space..........¥210,000*
NOTE: *fee includes 5% Japanese Consumption Tax

Booth Rental Fee includes (per 2,300mm x 2,000 mm booth space):

One (1) complimentary full-meeting registration
Two (2) complimentary exhibit booth personnel registrations
One (1) 1,800 x 550 mm table
Two (2) 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.

Exhibit Show Dates: July 11-12, 2013

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 1-5 of 5

BioClinica, Inc. / Suzuken Co., Ltd.
Certara G.K.
ERT Asia Group K.K.
Ina Research Inc.
SNBL Cardiac Safety Evaluation Center

Registration Fees

Member

Charitable Nonprofit/Academia Member: ¥25000.00
Member Government: ¥25000.00
Member Standard: ¥59000.00
Member Standard (As of 06/21/2013): ¥64000.00

Non-Member

Charitable Nonprofit/Academia Nonmember: ¥25000.00
NonMember Government: ¥40000.00
NonMember Standard: ¥79000.00

Group Discounts

There are no Group Discounts for this event.

CANCELLATION POLICY: On or before July 4, 2013, Administrative fee that will be withheld from refund amount:
Industry (Member or Nonmember) = 20,000 JPY
Government/Academia/Nonprofit (Member or Nonmember) = 10,000 JPY

Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable.

DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

Register Online

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