Press Release
Date and Time: December 16, 2019 from 1pm to 3pm
Agenda / List of Handouts
Agenda
- Introduction of the Subcommittee Members
- Appointment of Vice-chairperson
- About the Science Board
- Purpose of Establishment on the Subcommittee
- Points to Consider of Reviewing Medical Device Software Using Computer Simulation
- 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)
- Future Plan on the Subcommittee
- 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