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Overview

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To deliver drugs to patients with unmet medical needs as soon as possible, regulatory agencies must strengthen their review systems and shorten their review periods. Introducing expedited review systems, for example, will accelerate the development and delivery of new drugs from the regulatory side. R&D into new drugs by both companies and academia incorporate the latest science but still face challenges in addressing these unmet medical needs. Surrounding all this effort from industry, government and academia, the global development environment is also rapidly evolving day by day; grasping the impact of this evolution has become an important foundation for successfully meeting this challenge.

DIA’s 12th Asia New Drug Conference will share information on current and anticipated steps to collaboratively move forward. These include already established accelerated review pathways as well as progress and implementation of the ICH E17 guideline for planning and designing multiregional clinical trials, which will be specifically addressed by an expert panel followed by mutual discussion between our audience and speakers.

Experts from pharmaceutical companies and regulatory agencies will also provide the latest information about industry and regulatory challenges and initiatives, including next steps and how to proceed with tasks, in each Asian country. Topics related to risk and labeling management in various medical and regulatory environments have been prominently discussed in each country, and this conference provides a forum to further discuss these topics. We will also examine the remarkable change and recent regulatory reform introduced by the China FDA. DIA’s 12th DIA Asia New Drug Conference presents an opportunity for you to discover and consider new approaches for drug development in Asia. Now is the time for us to rise to meet this challenge. Now is the time for you to participate.

Who should attend?

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

Program Committee

  • Yoshikazu  Hayashi
    Yoshikazu Hayashi Associate Center Director (for New Drug Review)
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Ari  Fujishiro
    Ari Fujishiro Senior Director, Regulatory Affairs Group, Asia Development Dept., R&D Division
    Daiichi Sankyo Co., Ltd., Japan
  • Yoko  Aoi
    Yoko Aoi Reviewer, Office of New Drug IV
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Tomohisa  Hayakawa, PhD
    Tomohisa Hayakawa, PhD Senior Vice President, Business Development & Clinical Development
    EPS International Holdings Co., Ltd., Japan
  • In-Jin  Jang, MD, PhD
    In-Jin Jang, MD, PhD
    Seoul National University College of Medicine, Korea, Republic of
  • Jin  Shun, MBA
    Jin Shun, MBA Head, Regulatory Affairs, APAC
    Abbott Laboratories (Singapore) Pte. Ltd., Singapore
  • 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, Regulatory Science Innovation Section
    POC Clinical Research Inc., Japan
  • Shigeru  Nakaji, MSc
    Shigeru Nakaji, MSc Executive Director, Development Division
    Astellas Pharma Inc., Japan
  • Atsushi  Nonogaki, MSc
    Atsushi Nonogaki, MSc Manager, Regulatory Affairs Group, Asia Development Department, R&D Division
    Daiichi Sankyo Co., Ltd., Japan
  • Ling  Su, PhD
    Ling Su, PhD Professor
    Shenyang Pharmaceutical Univeristy, China
  • Crystal  Wang
    Crystal Wang Director of Development Division
    Chugai Pharma Taiwan Ltd., Taiwan
  • 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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