The 1st Subcommittee on Computer Simulation

Agenda

1. Introduction of the Subcommittee Members
2. Appointment of Vice-chairperson
3. About the Science Board
4. Purpose of Establishment on the Subcommittee
   • Points to Consider of Reviewing Medical Device Software Using Computer Simulation
5. Member's lecture
   • Overview of ASME V&V 40 (Dr. YAMADA Takahiro, a Member)
   • Evaluation Indices and R&D Guidelines Regarding the Use of Computational Simulation to the Evaluation of Medical Devices (Dr. CHINZEI Kiyoyuki, Chairperson on the Subcommittee)
6. Future Plan on the Subcommittee
7. Others

List of Handouts

• Document 1　List of the Subcommittee Members
• Document 2　About the Science Board
• Document 3　Points to Consider of Reviewing Medical Device Software Using Computer Simulation
• Document 4　Lecture Materials (Dr. YAMADA Takahiro, a Member)
• Document 5　Lecture Materials (Dr. CHINZEI Kiyoyuki, Chairperson on the Subcommittee)
• Document 6　Inputs from the Subcommittee Members on Focal Points and Applied Technologies
• Ref.1　Overview on Minutes of the 32th Science Board Meeting
• Ref.2　Provision of the Establishment of PMDA Science Board
• Ref.3　Provision of the PMDA Science Board Subcommittees
• Ref.4　Rules of Commission of the Member of the Science Board and the Subcommittees (to Avoid Conflict of Interests)
• Ref.5　Standards of Handling Meeting Minutes and Other Materials
• Ref.6　Points to Be Checked to Invite External Experts
• Ref.7　Points to Be Confirmed on Operation of the Working Group