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Overview

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With clinical development in Asia growing so rapidly, local regulatory authorities must quickly bring their processes and guidelines up to date and in alignment with the changing clinical trial environment throughout Asia.  However, this process has posed a significant challenge not only to regulatory authorities in charge of new product review and approval but to the pharmaceutical industry developing such products.  In addition to the increasing workload associated with more precise review, regulatory authorities must work with industry toward more efficient review and approval.
The 11th DIA Asia New Drug Conference in Japan will be held in Tokyo on April 17-18, 2017.  In this conference, experts from industry, academia, and regulatory authorities in East Asia will share the latest regulatory updates and experiences regarding the new drug development using multi-regional clinical trials (MRCTs) and provide advices on how to maximize the efficiency and productivity of MRCTs.  Another important topic is the newly-introduced ICH E17 guideline.  Experts who have contributed to this guideline will explain how it was developed, provide additional updates, and discuss this guideline with you.  With proactive pharmacovigilance throughout the product life cycle as the obvious way forward for safety and risk management in Asia, other critical topics include labeling and pharmacovigilance.  Although the challenge to standardize pharmacovigilance across the various geographical, cultural and medical practices in Asia remains, cooperation and convergence are indispensable.  The emerging ASEAN region is another critical topic this conference will explore. Experts from industry and regulatory authorities in the region will share their experiences and current information about new drug development in the ASEAN region along with advice about how to improve the value and quality of new drugs. 
At last year’s DIA Asia New Drug Conference in Japan, experienced speakers from East Asia, including China, actively discussed their current challenges and opportunities. This year, regulators from Asian countries and speakers with varied expertise will discuss how to most appropriately conduct MRCTs in this new era of globalized drug development and life cycle management.  Hot topics to catalyze fresh ideas will include the latest regulatory information, more efficient safety management strategies and processes, and the best approaches to MRCTs in Asia including a real-world case study.
The 11th DIA Asia New Drug Conference in Japan promises to be a most exciting opportunity for those seeking to broaden their professional network and learn how to maximize the efficiency and productivity of MRCTs in Asia.

Who should attend?

The program will benefit those with the following interests:
  • Clinical development
  • Regulatory affairs
  • Clinical study sites
  • CROs and SMOs
  • Medical affairs and market
  • Academic organizations
  • Regulatory agencies

Program Committee

  • Toshiyoshi  Tominaga, PhD
    Toshiyoshi Tominaga, PhD Associate Executive Director (for International Programs)
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Koichi  Miyazaki, MSc, RPh
    Koichi Miyazaki, MSc, RPh Senior Director, Clinical Group, Asia Development Dept., R&D Div.
    Daiichi Sankyo Co., Ltd., Japan
  • Yi  Feng
    Yi Feng SVP, Medical and Reg Affairs
    Fountain Medical Development Ltd., China
  • Ari  Fujishiro
    Ari Fujishiro Senior Director, Regulatory Affairs Group, Asia Development Dept., R&D Division
    Daiichi Sankyo Co., Ltd., Japan
  • Tomohisa  Hayakawa, PhD
    Tomohisa Hayakawa, PhD Senior Vice President, Business Development & Clinical Development
    EPS International Holdings Co., Ltd., Japan
  • Shun  Jin, MBA
    Shun Jin, MBA Head, Regulatory Affairs, APAC
    Abbott Laboratories (S) Pte. Ltd., Singapore
  • Yoshiko  Komuro, PhD
    Yoshiko Komuro, PhD Deputy Review Director, Office of New Drug II
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Jessica (Chih Min)  Lin, MBA, MSc
    Jessica (Chih Min) Lin, MBA, MSc General Manager of Development Division
    Chugai Pharma Taiwan Ltd., Taiwan
  • Rie  Matsui, RPh
    Rie Matsui, RPh Director, Regional Labeling Head for Asia, International Labeling Group
    Pfizer Japan Inc., Japan
  • Kosuke  Mitsui, MBA, MSc, PMP
    Kosuke Mitsui, MBA, MSc, PMP Senior Director, Clinical Research Department
    Chugai Pharma Science (Beijing) Co., Ltd., China
  • Tosei  Murase, PhD
    Tosei Murase, PhD Associate Manager, Japan-Asia Clinical Development 1, Development
    Astellas Pharma Inc., Japan
  • Ryuji  Nagata, PhD
    Ryuji Nagata, PhD Principal, Product Development Division
    POC Clinical Research Inc., Japan
  • Min Soo  Park
    Min Soo Park Chair
    KCGI, Korea, Republic of
  • Tetsuomi  Takano, RPh
    Tetsuomi Takano, RPh Senior Director, Administraion, External Relations
    Astellas Pharma Inc., Japan
  • Yoshiaki  Uyama, PhD
    Yoshiaki Uyama, PhD Director, Office of Medical Informatics and Epidemiology
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org

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