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Regulations & Services of PMDA
Information about Approved Products in Japan
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Information for approved products in Japan
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Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnostics
Information for approved products in Japan
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Regulations and services of PMDA
Information for approved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Reviews and Related Services
Post-marketing Safety Measures
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Reviews and Related Services
Post-marketing Safety Measures
Regulatory Science/The Science Board/Standard Development
The 5th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
Press Release
April 4, 2023 from 2pm to 4pm
Given the impact of COVID-19, the conference was held online.
Agenda / List of Handouts
Agenda
- How to compile a report
- Introduction
- Analysis of related trends in Japan and overseas
- Biases related to AI learning
- Problems of reuse of evaluation data in post-marketing learning and the current state of research to solve the problems
- New Approaches to Data Augmentation
- Current status and issues of training data construction by physical model simulation
- Perspectives on databases
- Others
List of Handouts
- Document 1 Summary of Discussions at the 4th Working Group
- Document 2 Initiatives of the AI Expert Subcommittee WG
- Document 3 Topic Note of Discussion
- Document 4 Agenda and Draft of Report (Repost of the 4th Subcommittee)
- Document 5 Biases related to AI learning
- Ref.1 Supplementary document related to ChatCAD
- Ref.2 Materials with comments to the discussion notes