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The European Medicines Regulations and the EU-Network Training Course

Feb 24 2014 9:00AM - Feb 25 2014 5:00PM | Urban Net Kanda Conference 3-6-2 Uchi Kanda, Chiyoda-ku, Tokyo 101-0047 Japan

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Overview 

Please note: the language of this training course will be English only, but Japanese speaking will be welcomed during group discussions.


This course will give you an overview of the European regulatory system to provide you with the tools you need to develop a successful regulatory strategy.

You will be given information about the different routes for obtaining a license for the European market, including centralized or decentralized procedures; mutual recognition procedures; national procedures; and the specific procedures for orphan drugs, pediatrics, advanced therapies, and combination products. The course will cover the different steps and timelines for each procedure, the clock-stops, the compiling of questions, and other key topics.

You’ll also receive a brief introduction to the unique set up of the European regulatory environment, including the different responsibilities of the European Commission, the member states, the European Medicines Agency (EMA), the National Competent Authorities (NCAs), and the Heads of Medicines Agencies (HMA).

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

Member Government
¥40000.00
Member Standard
¥86000.00
Nonprofit, Academia, Medicals (Member)
¥40000.00

Non-Member

Charitable, Academia, Medicals (Nonmember)
¥40000.00
NonMember Government
¥55000.00
NonMember Standard
¥101000.00
Group Discounts

There are no group discounts for this event.


CANCELLATION POLICY: On or before February 17, 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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