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The 1st Cellular and Tissue-based Products Subcommittee Meeting

Press Release

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Date and Time: September 24, 2012  from 5pm to 8pm

Agenda / List of Handouts

Agenda
  1. Joint Subcommittees Meeting
    1. The Science Board
      1. (1) Need for the Science Board
      2. (2) Role of the Science Board and the Subcommittees
      3. (3) Establishment of the Science Board and the Subcommittees
    2. Overview of the review process in PMDA
    3. Others
  2. Cellular and Tissue-based 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
  • Document 1 Needs for the Science Board
  • Document 2 Major roles of the Science Board and Subcommittees
  • Document 3-1 List of the Subcommittees members
  • Document 3-2 List of the Subcommittees members
  • Document 3-3 List of the temporarily members of the Subcommittees
  • Document 4-1 Provision of the establishment of the PMDA Science Board
  • Document 4-2 Provision of the establishment of the PMDA Science Board Subcommittees
  • Document 4-3 Rules of Commission of the member of the Science Board and the Subcommittees (to avoid conflict of interests)
  • Document 5 Overview of review process
  • Document 6 PMDA Organization Chart
  • Document 7 Non-disclosure standards of meeting minutes and related documents
  • Document 8 Examples of tasks of the Subcommittee
  • Document 9-1 Overview of review process (application material of antineoplastic drugs and clinical trial)
  • Document 9-2 Possible agenda of Cellular and Tissue-based Products Subcommittee
  • Document 9-3 Overview of medical devices review

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The 1st Cellular and Tissue-based Products Subcommittee Meeting
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