Biotek Salon#13: Japan as a target market – to do or not to do?

starter:15/01/2018 slutter:15/01/2018 fra:14:30 til:17:00 adresse:COBIS, Ole Maaløes Vej 3, 2200 Copenhagen N www: Link >> price:Free of charge for the members; non members: 500 DKK speaker:Masami Tamura Import to calendar
adresse:
COBIS, Ole Maaløes Vej 3, 2200 Copenhagen N
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Programme

  • 14:30
    Registration and networking
  • 15:00
    Welcome by Martin Bonde - Chairman, DANSK BIOTEK & Ann Christine Korsgaard - Regulatory Affairs Executive & Mg. Director, Biotrack
  • 15:10
    The Japanese environment for small pharmaceutical/biotech companies – foreign and domestic by Masami Tamura
  • -
    Japanese facts
  • -
    The Japanese regulatory environment through SME* eyes – any short cuts to early access?
  • -
    How to decide timing for Japanese involvement and related value drivers
  • -
    Who can help you?
  • -
    A case story of an SME achieving approval of their JNDA
  • 16:30
    Networking and refreshments

Venue: COBIS, Ole Maaløes Vej 3, 2200 Copenhagen N

Date: 15/01/2018

Time: 14:30 - 17:00

Masami Tamura (President & CEO, CoreMed) and Ann Christine Korsgaard (Regulatory Affairs Executive & Mg. Director, Biotrack) on the Japanese environment for small pharmaceutical/biotech companies – foreign and domestic.

The world is getting smaller and Japan is getting closer.

Join an opportunity to open your mind towards Japan and get some tips and tricks for how to evaluate the Japanese potential of your product. What could be done early on to increase the future value of your asset for Japanese patients?

Come and meet a Japanese expert who has developed a significant number of regulatory strategies for foreign pharmaceutical companies since 1998 at CoreMed. Each year, CoreMed works on 2-3 PMDA consultations and 2-3 JNDAs.

The aim of this meeting is to:

  • get tools for a fitted regulatory strategy towards Japan to facilitate early decision making in your development plan

If you can't find it here or have feedback to our website, please do not hesitate to contact dd@danskbiotek.dk or +45 5150 0560

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