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The 1st Bio-products Subcommittee Meeting

Press Release

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Monday, September 24, 2012   17:00-20:00

Agenda / List of Handouts

  1. Joint Subcommittees Meeting
    1. The Science Board
      1. (1) Need for the Science Board
      2. (2) Role of the Science Board and Subcommittees
      3. (3) Establishment of the Science Board and the Subcommittees
    2. Overview of the review process in PMDA
    3. Others
  2. Bio-products Subcommittee
    1. Introduction of subcommittee members and related PMDA staff members
    2. Overview of the related pharmaceutical systems and description of future issues
    3. Procedures of future discussions
    4. Schedule of the next meeting

List of Handouts

Seat Assignment
Classification of how to handle the Handouts
1. Needs for the Science Board
2. Major roles of the Science Board and the Subcommittees
3-1. List of the Science Board members
3-2. List of the Subcommittees members
3-3. List of the temporarily members of the Subcommittees
4-1. Provision of the establishment of the PMDA Science Board
4-2. Provision of the establishment of the PMDA Science Board Subcommittees
4-3. Rules of Commission of the members of the Science Board and the Subcommittees (to avoid conflict of interests)
5. Overview of review process
6. PMDA Organization Chart
7. Non-disclosure standards of meeting minutes and related documents
8. Examples of tasks of the Subcommittee
9-1. Overview of review process (application material of antineoplastic drugs and clinical trial)
9-2. Possible agenda of the Cellular and Tissue-based Products Subcommittee
9-3. Overview of medical devices review

Minutes

JCN 3010005007409

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

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The 1st Bio-products Subcommittee Meeting
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