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TOC Ariake Convention Hall

Apr 13, 2016 9:00 AM - Apr 14, 2016 6:00 PM

3-5-7 Ariake, , Koto-ku, Tokyo, 135-0063 Japan

10th DIA Asia New Drug Conference in Japan

The registrants will have access to presentation PDFs through Thursday, October 13, 2016.

Overview

Online registration has been closed, but we still accept your registration by email at japan@diaglobal.org or register at the venue. Please call at +03-6214-0574 for the details.

Click here to view the program.

We are proud to announce that 10th DIA Asia New Drug Conference in Japan on April 13-14, 2016. We updated the name of this conference from “DIA Annual Conference in Japan for Asian New Drug Development” to better reflect the broad range of issues to be discussed for better drug development and fostering of innovation in Asia.

With clinical development in Asia growing so rapidly, there is a need for local regulatory authorities to quickly bring their processes and guidelines up to date and to be in alignment with the changing clinical trial environment in each country. These efforts, however, have posed a significant challenge to regulatory authorities in charge of the review and approval of new products. In addition to an increasing workload associated with precise review, regulatory authorities must now contend with faster review and approval. The pharmaceutical industry is also changing its business model in response to recent regulatory changes.

Much the same is true on labeling and pharmacovigilance, including the Risk Management Plan, recently required in East Asia countries. An increase in drug safety concerns in recent years has led to raising the regulatory hurdles. Proactive pharmacovigilance throughout the product life cycle is the way forward in Asia region. It has been a constant challenge to standardize pharmacovigilance in Asia because of varied geographical, cultural and medical practices in this region. Given these challenges, the need for cooperation and convergence has been recognized. It is crucial for sustainable and successful drug development that all stakeholders collaborate closely and early in the development process of medical treatments.

At last year’s conference, regulators from four East Asian countries, including China, and regulatory affairs professionals from pharmaceutical companies in various countries had active discussions on current challenges and opportunities. This year, regulators from Asian countries and speakers with varied expertise will share their valuable experiences and insight to discuss what we can do better in the era of globalized drug development and life cycle management. A variety of hot topics that catalyze the creation of fresh ideas will be featured at the conference, including:
• The latest regulatory information
• A real-world case study of Asia MRCT
• Efficient drug development using Asia MRCT
• Efficient safety information management

The 10th DIA Asia New Drug Conference in Japan promises to be one of the most exciting opportunities for those who are seeking to broaden their professional network. We wish you all an enjoyable and informative conference.

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Continuing-Education

Exhibits

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 Project Professor
    Keio University Hospital, Japan
  • Koichi  Miyazaki, PhD
    Koichi Miyazaki, PhD Senior Director, Group IV, Oncology Clinical Development Department
    Daiichi Sankyo Co., Ltd., Japan
  • 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 Corporate Officer; Head of BD & PM
    EPS International Holdings Co., Ltd., Japan
  • Shun  Jin, MBA
    Shun Jin, MBA Head, Regulatory Affairs, APMA
    Sandoz Asia Pacific Pharmaceutical Pte., Ltd., Singapore
  • Akihito  Kakiuchi, MSc, RPh
    Akihito Kakiuchi, MSc, RPh Respiratory TA Office, Medicines Development, Japan Development &Medical Affairs
    GlaxoSmithKline K.K., Japan
  • Yoshiko  Komuro, PhD
    Yoshiko Komuro, PhD Inspection Director, Office of Non-Clinical and Clinical Compliance
    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 Senior Director, Regional Labeling Head for APAC, International Labeling
    Pfizer R&D Japan G.K., Japan
  • Kosuke  Mitsui, MBA, MSc, PMP
    Kosuke Mitsui, MBA, MSc, PMP President & General Manager
    Chugai Pharma Science (Beijing) Co., Ltd., China
  • Shiho  Noda, DVM
    Shiho Noda, DVM Japan/Asia Clinical Development 1, Astellas Pharma Global Development
    Astellas Pharma Inc., Japan
  • Minsoo  Park
    Minsoo Park
    KCGI, Korea, Republic of
  • Kihito  Takahashi
    Kihito Takahashi Head of R&D/Medical Affairs Hub Japan
    Swedish Orphan Biovitrium (SOBI) Japan, Japan
  • Tetsuomi  Takano, RPh
    Tetsuomi Takano, RPh Editor-in-Chief
    Drug R&D Expert, Japan
  • Xue  TANG
    Xue TANG Drug Safety Unit Regional Head (DRH),
    APAC Pfizer, China
  • Yoshiaki  Uyama, PhD, RPh
    Yoshiaki Uyama, PhD, RPh Associate Executive Director
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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