The 1st Science Board Meeting

Agenda

1. Opening address and explanation of the purpose of the Science Board from the Director General of the Office of Review Innovation
2. Establishment of the Science Board
3. Introduction of the participants
4. Appointment of Chairperson and Vice-chairperson of the Science Board
5. PMDA's current status and the Science Board
   1. (1) Current status of PMDA's review and consultation post-marketing safety measures and relief services
   2. (2) Challenges of PMDA and the role of the Science Board
      - Setting up the subcommittees and selection of Chairpersons / Deputy chairpersons of the subcommittees
      - Regarding the promotion program to be commercialized innovative drugs, medical devices and cell- and tissue-based products
   3. (3) Future plan
      - Free-form discussion
      - Schedule
6. Others
   The next meeting: July 31, 2012 10am to 12pm

List of Handouts

• Document 1　Needs for the Science Board
• Document 2　Provisions of the establishment of the PMDA  Science Board
• Document 3　List of the Science Board members
• Document 4　Rules of Commission of the members of the Science Board and the Subcommittees (to avoid conflict of interests)
• Document 5　Overview of review process of PMDA
• Document 6　Annual Report of FY2011 (draft)
• Document 7-1　The Science Board Subcommittees (proposal)
• Document 7-2　Example of the Tasks of the Subcommittees
• Document 8　FY 2012 proposed schedule of the Science Board
• Document 9　Promotion program to be commercialized Document 9 innovative drugs and medical devices and Cellular and Tissue-based Products
• Ref.1　Science Board of the U.S. FDA
• Ref.2　5-Year Strategy of Medical Innovation (Medical Innovation Meeting)
• Ref.3　List of the Science Board Members (with classification of professional areas)
• Ref.4　Recommended members of the Subcommittees as of June 13, 2012
• Ref.5　Points to be Considered by the Review Staff Involved in the Evaluation Process of New Drug
• Ref.6　Points to Consider in Preparing Applications for New Medical Devices
• Ref.7　List of Approved Products (New Drugs: April 2011 - April 2012)
• Ref.8　List of Approved Products (New Medical Devices: April - December 2011)
• Ref.9　Review report of new drugs
• Ref.10　Review report of new medical devices