Press Release
Date and Time: September 24, 2012 from 5pm to 8pm
Agenda / List of Handouts
Agenda
- Joint Subcommittees Meeting
- The Science Board
- (1) Need for the Science Board
- (2) Role of the Science Board and the Subcommittees
- (3) Establishment of the Science Board and the Subcommittees
- Overview of the review process in PMDA
- Others
- The Science Board
- Medical Devices Subcommittee
- Introduction of subcommittee members and related PMDA staff members
- Overview of the related pharmaceutical systems and description of future issues
- Procedures of future discussions
- 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