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2nd CMC Forum in Japan

Jun 10 2013 9:30AM - Jun 10 2013 7:00PM | KFC Hall 1-6-1 Yokoami Sumida-ku Tokyo 130-0015 Japan

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Overview 

Simultaneous Interpretation Available


A trend has been observed that global pharmaceutical companies, including generic pharmaceutical companies, are increasingly importing pharmaceutical products and/or drug substances that are manufactured around the world to sell in Japan.With this growth in importations the supply chain for these products has become more complicated. While there are some efforts to harmonize regulations worldwide, for example the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), differences remain in the inspection and other quality control activities of various countries.  The inspections carried out by each country’s regulatory agency and audits undertaken by pharmaceutical companies are vital for maintaining quality.

The 2nd CMC Forum in Japan will focus on inspection and audit activities for Chemistry, Manufacturing and Controls (CMC) quality improvement around the world. DIA Japan hope this symposium will help the participants find solutions to take steps towards the global harmonization of quality improvement.

The symposium will feature lectures from inspectors and auditors who play an active role in quality improvement and regulation, including Pharmaceuticals and Medical Devices Agency (PMDA) inspectors. This is useful opportunity for drug substance manufacturers and new drug development, generic, pharmaceutical trading, and OTC companies to share important experience and challenges. DIA Japan hopes you can attend this valuable forum.

Who Should Attend 

This program will benefit the following individuals:

  • Regulatory Affairs
  • CMC Regulatory Affairs
  • CMC Writing
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • API Development and Manufacturing
  • Formulation Development and Manufacturing
  • Supply Chain Management
  • Analytical Development
  • CMC Life Cycle Management
  • CMC Project Management

Hotel & Travel 

There are a limited number of rooms at the Dai-ichi Hotel Ryogoku at a reduced rate shown below. Room availability at this rate is guaranteed only until May 19, 2013 or until the room block is filled. Attendees should make their airline and room reservations as soon as possible.

Standard Room Single ¥ 11,000/night

Dai-ichi Hotel Ryogoku
1-6-1 Yokoami, Simida-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/english/index.html
To reserve your room, please contact the Dai-ichi Hotel Ryogoku above and mention the DIA Meeting.

Contact Information 

Tabletop Exhibit Opportunity
Please contact DIA Japan for details about tabletop exhibits.
Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
email: DIAJapan@diajapan.org

Program Committee 

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Agenda  

Day 1 Monday, June 10, 2013

  • 10:00AM - 10:10AM

    Welcome and Opening Remarks
  • 10:10AM - 11:40AM

    Session 1: Role and Company Expectation for PIC/S


    Session Chair(s):

    • Akira Kato, PhD
      Senior Director, Global Formulation Research, Japan, Pharmaceutical Science & Te
      Eisai Product Creation Systems, Japan
    • Noriko Katori, PhD
      Chief of Third Section, Division of Drugs
      National Institute of Health Sciences, Japan

    Speaker(s):

    • Hirofumi Ueda
      Director for GMP Inspection, GMP Audit, Office of GMP/QMS Inspection
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Hitoshi Mori
      Sanofi K.K., Japan
    • Yasuto Koyama
      Corporate Quality Assurance Dept, Quality, Safety and RA Management Division
      Shionogi & Co., Ltd., Japan
  • 12:40PM - 2:30PM

    Session 2: What is Visible from Actual Audit/Inspection


    Session Chair(s):

    • Rumiko Shimazawa, PhD
      Research Associate Professor, Center for Clinical and Translational Research
      Kyushu University Hospital, Japan
    • Nobuyuki Suzuki, PhD
      Senior Director, Analytical Science Research Group I
      Daiichi Sankyo Co., Ltd., Japan

    Speaker(s):

    • Hirofumi Ueda
      Director for GMP Inspection, GMP Audit, Office of GMP/QMS Inspection
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Takayoshi Matsumura
      Advisor
      NPO-QA Center, Japan
    • Eize de Boer, PhD
      International Business Development Manager, Life Science Industry
      SGS, Switzerland
  • 3:00PM - 4:30PM

    Session 3: Challenge for Quality Improvement


    Session Chair(s):

    • Haruhiro Okuda, PhD
      Director
      National Institute of Health Sciences, Japan
    • Fusashi Ishikawa, PhD
      Group Manager, Solid Dosage Form Rearch Group III
      Dainippon Sumitomo Pharma Co., Ltd., Japan

    Speaker(s):

    • Gyu-han Chae
      Deputy Director / Planning Expert, Pharmaceutical Policy Division
      Ministry of Food and Drug Safety (MFDS), Korea, Republic of
    • Ryuji Nagata, PhD
      Reviewer, Pharmaceutical Policy Division
      Ministry of Food and Drug Safety (MFDS), Korea, Republic of
    • Armin Hoffmann
      Global Regulatory Affairs Director
      Aesica Pharmaceuticals GmbH, Germany
  • 4:30PM - 5:30PM

    Panel Discussion
  • 5:30PM - 5:40PM

    Closing Remarks

Exhibits  

The 2nd CMC Forum in Japan offers interested companies the opportunity to exhibit with a tabletop display.

Fee:
2,300 x 2,000 mm booth space..........¥105,000*
NOTE: *fee includes 5% 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 ¥12,600 each (limit of 3 per booth space) - please use the Additional Exhibit Booth Personnel Registration Form under Useful Links to register additional staff.

Exhibit Show Date: June 10, 2013

Useful Links:

  • ASKLEP Inc.

Registration Fees 

Member

Charitable Nonprofit/Academia Member
¥15000.00
Member Government
¥15000.00
Member Standard
¥32000.00

Non-Member

Charitable Nonprofit/Academia Nonmember
¥22500.00
NonMember Government
¥22500.00
NonMember Standard
¥39500.00
Group Discounts

There are no Group Discounts for this event.


Cancellation Policy: On or before June 3, 2013, Administrative fee that will be withheld from refund amount:
Member or Nonmember = 20,000 JPY
Government/Academia/Nonprofit
(Member or Nonmember) = 10,000 JPY

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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