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3rd FDA IND/NDA Training Course in Japan

Jun 10 2014 10:00AM - Jun 11 2014 5:30PM | Kyoto Research Park 134 Chudoji Minami-machi, Shimogyo-ku, Kyoto 600-8813 Japan

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Overview 

The process of new drug development has become increasingly global in the past two decades. Many companies are conducting multinational clinical studies and aiming for simultaneous submission of New Drug Applications to Japan, the US, and the EU.

The globalization of the pharmaceutical industry means that it is no longer enough for regulatory and development staff and managers in Japanese pharmaceutical companies to understand only the Japanese regulations and process of drug development. It is now essential for professionals in the field to understand the regulations, processes, and trends in other countries that participate in global drug development.

For several years DIA has offered regular training for FDA IND/NDA in the US. The course is very popular and many international people, including Japanese, have attended. DIA Japan has brought this course to Japan in 2012 (Hakone) and 2013 (Tokyo), customized for professionals in the region, and is offering it in Kyoto in 2014.

The training features:

Two-day program providing necessary knowledge for Japanese professionals

Focus on regulations and processes (IND and NDA)

How to work productively and efficiently with FDA

Practical workshops providing opportunities for discussion to deepen understanding

The trainers are Dr. Alberto Grignolo and Dr. Michael Hamrell, who are two of the faculty and planners of the original FDA IND/NDA training in the US. The course will be conducted in English except for discussion and Q&A.

This training will be fit for regulatory and clinical development professionals who are intending/planning US submissions and clinical trials or similar projects.

Hotel & Travel 

Kyoto Tokyu Hotel is convenient accommodation in terms of transportation. To reserve, please contact the Kyoto Tokyu Hotel below.


Address: Gojo-sagaru, Horikawa-dori, Shimogyo-ku, Kyoto-shi, Kyoto 600-8519, Japan

Telephone: +81 75 341 2411/ Fax: +81 75 341 2488

URL: http://www.kyoto-h.tokyuhotels.co.jp/en/

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

Faculty 

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Registration Fees 

Member

Charitable Nonprofit/Academia/Medicals Member
¥40000.00
Member Government
¥40000.00
Member Standard
¥86000.00

Non-Member

Charitable Nonprofit/Academia/Medicals Nonmember
¥40000.00
NonMember Government
¥55000.00
NonMember Standard
¥101000.00
Group Discounts

There are no group discounts for this event.


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

CANCELLATION POLICY: On or before June 3, 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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