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Tokyo Big Sight

Oct 08, 2022 3:40 PM - Oct 09, 2022 12:10 AM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

DIA Asia Meeting 2022

Digital Transformation in Clinical Development and Product Information

Overview

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Those who have registered for the 19th DIA Japan Annual Meeting 2022 are entitled to a "50% discount" on the registration fee for the DIA Asia Meeting 2022. Please apply by fax or e-mail with the application form.

Since 2007, the DIA Asia Meeting has provided a platform for industry, regulators, and academics to solve research challenges in Asia. Countries sharing their knowledge of regulatory application packages through this platform, including inclusion of data from global clinical trials and local Asian populations, have driven successful regulatory applications throughout Asia.

DIA Asia Meeting 2022 will be presented on October 8 in Tokyo on the theme of Digital Transformation. As in every previous DIA Asia Meeting, our program committee consists of colleagues from Japan, South Korea, China, and Singapore.
Participating Asian countries will review recent innovative approaches to clinical trial conduct and other advancements in drug development, including the digital transformation of clinical operations, data management and analytics, and pharmacovigilance. Regulatory innovation in product labelling and safety information management, as well as future directions for global and Asian clinical trials, will also be discussed.

Session 1:  Dr. Theresa Mullins of US FDA and PMDA Chairperson Dr. Yasuhiro Fujiwara will be joined by senior officials from Singapore HSA and China’s health authority to share information and discuss how each country (including the US and European Union) can advance Digital Transformation in the future.

Session 2: Speakers will discuss the practical aspects of digital transformation and innovation in clinical and academic research operations, including challenges encountered with data sourcing from medical records, and how decentralized operations can provide a comprehensive, interoperable solution for clinical trial conduct and oversight.

Session 3: Speakers will share information on pharmacovigilance initiatives in Asia, including collecting post-market safety data and implementing digital product information, and how a planned international product information standard could be used in the EU, Japan, and US to provide patient-centric benefits now and in the future.

Integration between sessions 2 and 3 will allow overall discussion of product information across the entire spectrum of development through post-marketing.

We are all hopeful that the pandemic will end soon. We are confident that the lessons we learned from the pandemic, combined with the acceleration of on going Digital Transformation, will enhance the efficiency of clinical and academic research and regulatory operations. We sincerely hope that DIA Asia Meeting 2022 provides the discussion forum that makes a positive impact on society by making new drugs available earlier, and more accessible, to Asian and global patients.

October 8 is also the day before our 19th DIA Japan Annual Meeting 2022. We hope this gives you the opportunity to participate in both meetings.

Japanese/English simultaneous interpretation available

Participants:
Those involved in

  • Clinical trials, data management, and big data
  • Product information, Package inserts, safety management work, post-marketing surveillance
  • Clinical trials and product information in medical field
  • The development of electronic medical records and electronic receipt systems
  • System development in pharmaceuticals and medical care
  • Regulatory authorities

Featured

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Exhibits

Program Committee

  • Hironobu  Saito, PhD
    Hironobu Saito, PhD Specially Appointed Professor
    Tottori University, Chromosome Egineering Research Center, Japan
  • Ling  Su, PhD
    Ling Su, PhD Research Fellow
    Shenyang Pharmaceutical University, Yeehong Business School, China
  • Shun  Jin, MBA
    Shun Jin, MBA Head, Regulatory Affairs, APMA
    Sandoz Asia Pacific Pharmaceutical Pte., Ltd., Singapore
  • Yil-Seob  Lee, MD, PhD
    Yil-Seob Lee, MD, PhD Professor, Dept of Clinical Pharmacology
    CHA Global clinical research center, CHA University, Korea, Republic of
  • Kum Cheun  Wong, PharmD
    Kum Cheun Wong, PharmD Head Asia Pacific Regulatory & Development Policy
    Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore
  • Toshihiko  Doi, MD, PhD
    Toshihiko Doi, MD, PhD Deputy Director / Chief, Experimental Therapeutics
    National Cancer Center Hospital East, Japan
  • Fengyun (Vicky)  Han
    Fengyun (Vicky) Han Senior Director, Head of Regulatory Policy for Asia Pacific
    Johnson & Johnson Pte. Ltd., Singapore
  • Hyung-Jin  Jung, MD, MBA
    Hyung-Jin Jung, MD, MBA Medical Director
    Bayer Korea, Ltd, Korea, Republic of
  • Joyce  LIU
    Joyce LIU Vice President, Head of Regulatory Affairs, Greater China, Takeda
    Takeda Greater China, China
  • Rie  Matsui, RPh
    Rie Matsui, RPh Senior Director, Regional Labeling Head for APAC, International Labeling
    Pfizer R&D Japan G.K., Japan
  • Hyouyoung  Rhim, MD, MSc
    Hyouyoung Rhim, MD, MSc Vice President
    Yuhan Pharm inc., Korea, Republic of
  • Junko  Sato, PhD
    Junko Sato, PhD Associate Executive Director
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Eri  Sekine
    Eri Sekine Executive Vice President
    CMIC Group, Japan
  • Hualong  Sun
    Hualong Sun General manager
    Meta Clinical Technical Co. Ltd, China
  • Xiaojun (Wendy)  Yan, MD, MBA
    Xiaojun (Wendy) Yan, MD, MBA Senior Vice President, Senior Advisor
    BeiGene (Beijing) Co., Ltd., China
  • Jing Ping  Yeo, PhD
    Jing Ping Yeo, PhD Global Head, Project Operations & Head, Transformation
    George Clinical, Singapore
  • Masafumi  Yokota, DVM, PhD
    Masafumi Yokota, DVM, PhD Senior Director
    Daiichi Sankyo Co., Ltd., Japan

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