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3rd DIA CMC Forum in Japan

Jun 30 2014 9:40AM - Jun 30 2014 5:30PM | KFC Hall 1-6-1 Yokoami Sumida-ku Tokyo 130-0015 Japan

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The development of biosimilar is currently a hot topic across the world. Japan, like many other countries, is seeing an increase in the number of biosimilars in development for the medical field.

However, as yet, there is no tight consensus or guidelines on how to handle the development of biosimilars. These products are not on the table of ICH discussion and there is no harmonization so far. In the EU some development guidelines have been created and there are many biosimilars on the market, while in the US the biosimilar category has just been created.

DIA Japan’s 3rd CMC Forum will provide an opportunity for key stakeholders to discuss their experiences in the development of biosimilars. Participants will learn about the EU biosimilar guidelines and hear from pharmaceutical professionals and regulatory authorities in the EU. Attendees will also discuss the key challenges for the future of biosimilar product development, particularly similarity with existing products.

This event offers a forum not only for companies that are currently developing biosimilars, but also those that are considering developing biosimilars in the future and that provide development support CRM. We would like to invite professionals in CMC, clinical development, regulatory and business development to join us in Tokyo.

Special pricing for PDA/ISPE members

If you are a member of either Parenteral Drug Association (PDA) or International Society for Pharmaceutical Engineering, Inc., please apply for this meeting via FAX or E-Mail.

Who Should Attend 

This program will benefit the following individuals:

  • Regulatory Affairs
  • CMC Regulatory Affairs
  • Formulation Development and Manufacturing
  • Analytical Development
  • Biopharmaceutical Development and Manufacturing
  • CMC Life Cycle Management
  • CMC Project Management
  • Clinical Development
  • Business Development

Hotel & Travel 

Dai-ichi Hotel Ryogoku is convenient accomodation adjacent to the venue. To reserve, please contact the Dai-ichi Hotel Ryogoku below.
Address: 1-6-1 Yokoami, Sumida-ku, Tokyo 130-0015, Japan
Telephone: +81-(0)3-5611-5211 / Fax: +81-(0)3-5611-5212
email: daiichi-hotel@dh-ryogoku.com
URL: http://www.dh-ryogoku.com/english/index.html

Contact Information 

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

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200

Program Committee 

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Day 1 Monday, Jun 30, 2014

  • 9:40AM - 9:50AM (Tokyo Standard Time)



    • Ko Sekiguchi, MBA
      Representative Director
      DIA Japan, Japan
    • Fusashi Ishikawa, PhD
      Group Manager, Formulation R&D Laboratories
      Sumitomo Dainippon Pharma Co., Ltd., Japan
  • 9:50AM - 10:20AM (Tokyo Standard Time)

    What is Biosimilar? Development Overview


    • Teruyo Arato, PhD
      Professor, Department of Regulatory Science
      Hokkaido University Graduate School of Medicine, Japan
  • 10:20AM - 10:50AM (Tokyo Standard Time)

    Expectations for Biosimilars


    • Shinji Miyake, PhD
      Professor, Center for Clinical Research
      Keio University School of Medicine, Japan
  • 10:50AM - 11:20AM (Tokyo Standard Time)

    The Challenges of Proof of Similarity for Biosimilar Development


    • Nana Kawasaki, PhD
      Head, Division of Biological Chemistry and Biologicals
      National Institute of Health Sciences, Japan
  • 11:20AM - 11:50AM (Tokyo Standard Time)

    Application of QbD Tools for Biosimilar Products


    • Martin Schiestl, PhD
      Scientific & Regulatory Advisor
      Sandoz, Austria
  • 1:00PM - 1:30PM (Tokyo Standard Time)

    Experience of Biosimilar Development 1 - CMC Perspective


    • Koki Murakami, PhD
      Principal Scientist, Global CMC Japan
      Pfizer Japan Inc., Japan
  • 1:30PM - 2:00PM (Tokyo Standard Time)

    Our Experience on Development of Erythropoietin Biosimilar and What Next?


    • Zen-ichi Mohri
      Advisor for Development
      JCR Pharmaceuticals Co., Ltd., Japan
  • 2:00PM - 2:30PM (Tokyo Standard Time)

    Review of Biosimilars in Japan


    • Reiko Yanagihara, PhD
      Principal Reviewer, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 2:30PM - 3:00PM (Tokyo Standard Time)

    The Current Situation of Biosimilars Worldwide


    • Akiko Ishii, PhD
      Section Chief, Division of Biological Chemistry and Biologicals
      National Institute of Health Sciences, Japan
  • 3:30PM - 4:30PM (Tokyo Standard Time)

    The Evolution of EU Guidelines and the Current Situation for Biosimilars


    • Klara Tiitso, MSc
      Scientific Administrator
      European Medicines Agency, United Kingdom
  • 4:30PM - 5:30PM (Tokyo Standard Time)

    Panel Discussion

    Session Chair(s):

    • Fusashi Ishikawa, PhD
      Group Manager, Formulation R&D Laboratories
      Sumitomo Dainippon Pharma Co., Ltd., Japan
    • Toru Kawanishi, PhD
      Director General
      National Institute of Health Sciences, Japan


The 3rd CMC Forum in Japan offers interested companies the opportunity to exhibit with a tabletop display.

Booth Rental Fee: 2,300 x 2,000 mm booth space..........¥108,000*
NOTE: *fee includes 8% Japanese Consumption Tax

Booth Rental Fee includes (per 2,300mm x 2,000 booth space):

  • One (1) complimentary full-meeting registration
  • Two (2) complimentary exhibit booth personnel registrations
  • One (1) 1,800 x 450 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 to register additional staff.

Exhibit Show Date: June 30, 2014

Useful Links:

  • Multipharma Ltd

Registration Fees 


Charitable Nonprofit/Academia Member/Medicals
Member Government
Member Standard


Charitable Nonprofit/Academia Nonmember/Medicals
NonMember Government
NonMember Standard
Group Discounts

Online registration is no longer available.

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

CANCELLATION POLICY: On or before June 23, 2014
Administrative fee that will be withheld from refund amount:
Member or Nonmember = ¥20,000
(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.

Register Online
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