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The 3rd Pharmaceuticals Subcommittee Meeting

Press Release

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(Joint Meeting with Bio-products Subcommittee)
Wednsday, January 30, 2013   17:00 - 19:00

Agenda / List of Handouts

  1. Personalized medicine
    • (1) Current situation explained by the Subcommittee members
    • (2) Regulatory trend of personalized medicine
  2. Ways to proceed future discussions of Pharmaceuticals Subcommittee and Bio-products Subcommittee Subcommittee
  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 a discussion 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

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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The 3rd Pharmaceuticals Subcommittee Meeting
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