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8th DIA Annual Conference in Japan for Asian New Drug Development

May 22 2014 10:00AM - May 23 2014 6:10PM | Sola City Conference Center 4-6 Kandasurugadai, Chiyoda-ku, Tokyo 101-0062 Japan

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Overview 

Drug development in East Asia has become extremely vigorous as the interests of organizations related to drug development expand. Such organizations are now not only interested in the advancement of drug development, but also the maximization of generated value and the improvement of quality in new drug development. In order to facilitate drug discovery under the revised regulations for optimal regulatory circumstances, professionals involved in drug development face various challenges. Furthermore, collaboration to work towards drug discovery beyond each country’s boundaries is strongly desired in this era of globalization of drug development.

Speakers from regulators and academia in Japan, China and Korea will share information and experiences regarding the current situation of new drug development in the emerging East Asia regions, and provide advice on how to imporve the value and quality of new drugs.

We look forward to welcoming you to the conference.


Simulatneous Translation Available

Featured Topics 

The 8th DIA Annual Conference in Japan for Asian New Drug Development will feature discussion on all stages of drug development, with sessions focused on the following topics:
  • Latest regulatory information
  • Early phase clinical trial
  • Collaboration between academic organizations
  • Regulatory inspection
  • Regional study communications
  • Late phase development strategy

Who Should Attend 

  • Clinical development professionals
  • Personnel involved in regulatory affairs
  • Personnel at clinical study sites
  • Personnel at CROs and SMOs
  • Personnel involved in medical affairs and marketing
  • Personnel at academic organization
  • Personnel at agency

Hotel & Travel 

Please make your own travel arrangement for transportation and accommodation.

Contact Information 

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

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAJapan@diajapan.org
www.diajapan.org

Program Committee 

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Agenda  

Day 1 Thursday, May 22, 2014

  • 10:00AM - 10:10AM (Tokyo Standard Time)

    WELCOME AND OPENING REMARKS
  • 10:10AM - 11:30AM (Tokyo Standard Time)

    KEYNOTE SESSION


    Session Chair(s):

    • No-image Ari Fujishiro
      Associate Director, Regulatory Affairs Group, Asia Development Dept
      Daiichi Sankyo Co., Ltd., Japan
    • No-image Hidetoshi Shuto
      Senior Fellow, Corporate Research & Development Div.
      Nitto Denko Corporation, Japan

    Speaker(s):

    • New Drug Development in Asian Region - from Japanese Company Perspective
      Hidetoshi Shuto
      Senior Fellow, Corporate Research & Development Div.
      Nitto Denko Corporation, Japan
    • Strategies for Asia Drug Development: An Integrated Approach
      Mark Bach, MD, PhD
      Vice President and Head, Asia Pacific Medical Sciences
      Janssen, Pharmaceutical Companies of Johnson & Johnson, Singapore
  • 1:00PM - 2:30PM (Tokyo Standard Time)

    SESSION1-1: Academia Collaboration in East Asia


    Session Chair(s):

    • Yasuto Otsubo
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Jisin Yang, MD
      Global Clinical Program Director, Japan R&D
      CSL Behring K.K., Japan

    Speaker(s):

    • Academia Collaboration between Japan and Korea
      In-Jin Jang, MD, PhD
      Professor and Director, Department of Clinical Pharmacology and Therapeutics
      Seoul National University College of Medicine and Hospital, Korea, Republic of
    • Roles of Academia and its Networks for Asian Collaboration in Clinical Trials
      Yuji Kumagai, MD, PhD
      Director, Clinical Trial Center
      Kitasato University East Hospital, Japan
    • Academia Collaboration in East Asia: Opportunities and Challenges
      Haiyan LI, MD
      Professor of Cardiology, Director of Clinical Trial Center
      Peking University Third Hospital, China
  • 3:00PM - 4:00PM (Tokyo Standard Time)

    SESSION1-2: Early Phase and Regional Clinical Trials in Asia

    Speaker(s):

    • Unique Strategy for Asian Oncology Development in an Early Phase by a Pharmaceutical Company
      Morihiro Watanabe, MD, PhD
      Head, Clinical Development Center, R&D Japan, North East Asia Hub
      Merck Serono Co., Ltd., Japan
    • Early Clinical Trials in Korea
      Yung-Jue Bang, MD, PhD
      Professor, Internal Medicine
      Seoul National University Hospital, Korea, Republic of
  • 4:15PM - 5:30PM (Tokyo Standard Time)

    SESSION1-3: Panel Discussion

Day 2 Friday, May 23, 2014

  • 8:30AM - 9:30AM (Tokyo Standard Time)

    SESSION2-1: East-Asian Regulatory Update on Global Clinical Trials


    Session Chair(s):

    • Yasuto Otsubo
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Min Soo Park, MD, PhD
      Director, Clinical Trials Center, Severance Hospital
      Yonsei University College of Medicine, Korea, Republic of

    Speaker(s):

    • Global Clinical Review for Drug Approval in China
      Tao Wang
      Deputy Director, Division II of Clinical Trial for Pharmaceuticals, CDE
      China Food and Drug Administration (CFDA), China
    • Recent Status of Regulation and Clinical Trial in Korea
      Myung Jung Kim, MS
      Director, Clinical Trials Management Div, Pharmaceutical Safety Bureau
      Ministry of Food and Drug Safety (MFDS), Korea, Republic of
    • Global Clinical Data Evaluation for Drug Approval in Japan
      Yasuto Otsubo
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 9:30AM - 12:30PM (Tokyo Standard Time)

    SESSION2-2: Trend of GCP Inspection


    Session Chair(s):

    • No-image Ari Fujishiro
      Associate Director, Regulatory Affairs Group, Asia Development Dept
      Daiichi Sankyo Co., Ltd., Japan
    • No-image Akio Uemura, PhD
      Senior Director, Head of Global Drug Development and Regulatory Affairs Japan
      Allergan Japan K.K., Japan

    Speaker(s):

    • An Overview of the FDA GCP Inspection Process and Key Trends
      Ann Meeker-O'Connell, MS
      Senior Director, QA Clinical Strategy Team Lead
      Janssen Pharmaceuticals, Inc., United States
    • PMDA's Experiences on Foreign GCP Inspection: Focusing on Asian Region
      Tomoko Ohsawa, PhD
      Director for Personnel Coordination, Office of General Affairs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • MFDS's Perspective of Regulatory Inspection in Korea
      Ho Jin Oh, PharmD
      Assistant Director, Clinical Trials Management Div, Pharmaceutical Safety Bureau
      Ministry of Food and Drug Safety (MFDS), Korea, Republic of
    • Status of Regulatory Policies and Approval for Pharmaceutical Products in China
      Jiangping Dong
      Division Head, Division of Pharmaceuticals, Department of Drug Registration
      China Food and Drug Administration (CFDA), China
  • 2:00PM - 3:30PM (Tokyo Standard Time)

    SESSION3-1: Effective and Efficient Communication in Asia Regional Studies


    Session Chair(s):

    • Tomohisa Hayakawa, PhD
      Corporate Officer, Senior Vice President
      EPS International Holdings Co., Ltd., Japan
    • No-image Koichi Miyazaki, MSc, RPh
      Senior Director, Regulatory Affairs Group, Asia Development Dept
      Daiichi Sankyo Co., Ltd., Japan

    Speaker(s):

    • How Can We Efficiently Manage Asian Studies - From Sponsor's Perspective
      Kensuke Morimoto
      Manager, Clinical Development Group, Asia Development Dept., R&D Div.
      Daiichi Sankyo Co., Ltd., Japan
    • Effective Communication in Regional Clinical Studies
      James Cheong, MBA, RPh
      VP, Clinical Development
      EPS International, Singapore
    • Phase 3b Studies of Rotigotine Patch in Asian Countries During Regulatory Review Period in Japan
      Junji Ikeda
      Director, Clinical R&D
      Otsuka Pharmaceutical Co., Ltd., Japan
  • 4:00PM - 5:00PM (Tokyo Standard Time)

    SESSION3-2: Development Strategy Based on Healthcare System in Each Country

    Speaker(s):

    • NDA Submission of Eribulin Mesilate in Asia "On the NDA Submission in Korea"
      Tatsuo Watanabe, PhD
      Senior Director, Medical Planning Section, Oncology hhc Unit, Eisai Japan
      Eisai Co., Ltd., Japan
    • Medical Administration and Pharmaceutical Market in China - Present and Future Trend
      Shingo Shigemura
      President
      CMJ Pharma, China
  • 5:00PM - 6:00PM (Tokyo Standard Time)

    SESSION3-3: Panel Discussion
  • 6:00PM - 6:10PM (Tokyo Standard Time)

    CLOSING REMARKS

Exhibits  

The 8th Annual Workshop in Japan for Asian New Drug Development offers interested companies the opportunity to exhibit with a tabletop display.

Fee:
2,300 x 1,700 mm booth space..........¥216,000*
NOTE: *fee includes 8% Japanese Consumption Tax

Booth Rental Fee includes (per 2,300mm x 1,400m booth space):

  • Two (2) complimentary full-meeting registrations*
  • One (1) complimentary exhibit booth personnel registration*
  • One (1) 1,800 x 4500 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 ¥12,960 each (limit of 3 per booth space) - please use the Additional Exhibit Booth Personnel Registration Form under Useful Links to register additional staff.

* Special Offer (number of included full-meeting and booth personnel registrations) for this meeting only

Exhibit Show Dates: May 22-23, 2014

Useful Links:

  • ADM Korea Inc.
  • A-PACT (Alliance for Pac-Asia Clinical Trials)
  • BioClinica Inc.
  • Covance
  • ERT Asia Group K.K.
  • INC Research Japan K.K.
  • LSK Global Pharma Services Co., Ltd.
  • Pharmaceuticals and Medical Devices Agency (PMDA)
  • Quintiles Transnational Japan K K
  • SunFlare Co., Ltd.
  • Veeva Japan K.K.
  • Vitalograph

Registration Fees 

Member

Member Academia
¥25000.00
Member Government
¥25000.00
Member Standard
¥64000.00

Non-Member

NonMember Academia
¥25000.00
NonMember Government
¥40000.00
NonMember Standard
¥79000.00
Group Discounts

There are no group discounts for this event.


On-site registration will be available at the meeting venue.

Join DIA now to qualify to save on future events and to receive all the benefits of membership.

CANCELLATION POLICY: On or before May 15, 2014, Administrative fee that will be withheld from refund amount:

  • Industry (Member or Nonmember) = ¥20,000
  • Government/Academia/Nonprofit (Member or Nonmember) = ¥10,000

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.

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