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The 3rd Bio-products Subcommittee Meeting

Press Release

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(Joint Meeting with the Pharmaceuticals Subcommittee)
 Wednesday, January 30, 2013   17:00-19:00

Agenda / List of Handouts

  1. Peersonalized medicine
    (1) Current situation explained by the Subcommittee members
    (2) Regulatory trend of personalized medicine
  2. Ways to proceed future discussions of the Pharmaceuticals Subcommittee and the Bio-products Subcommitteee
  3. Others

List of Handouts

Seat Assignment
Classification of how to handle the Handouts
1. FDA’s approach on drug-drug interactions and personalized medicine
(Material provided by Dr. Yuichi Sugiyama, a member of the Science Board)
2-1. Current situation and issues of personalized medicine
(Material provided by Dr. Atsushi Ohtsu, a member of the Pharmaceuticals Subcommittee) *
2-2. Current situation and issues of personalized medicine
(modified version of the handout 2-1 for release)
3. Regulatory trend of personalized medicine and companion diagnostics
4. Ways to proceed to discussions at the Pharmaceuticals Subcommittee and the Bio-products Subcommittee
5. Pharmacology study of anticancer pharmaceuticals
6. Proposed measures on pharmacology study of anticancer pharmaceuticals by the Pharmaceuticals & the Bio-products Subcommittees
Ref 1. Targeted outcomes of the Subcommittees
Ref 2. Partial amendment of the Pharmaceuticals Affairs Law

* Document includes non-disclosure information and not uploaded.

Minutes

JCN 3010005007409

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Chiyoda-ku, Tokyo 100-0013 Japan

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