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  • Recent Developments in Regulation and Review of Programmed Medical Devices and the Drug Evaluation Committee (Webinar: February 8, 2024)

Drug Evaluation Committee Recent Developments in Regulation and Review of Programmed Medical Devices and the Drug Evaluation Committee (Webinar: February 8, 2024)

Feb 29, 2024

  • 00_Program (236KB)
  • 01_Responses of the Pharmaceuticals Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan on SaMD (0.8MB)
  • 01_Responses of the Pharmaceutical Cooperative Medical Devices Evaluation Committee on SaMD (YouTube video)
  • 02_Regulatory Update on Programmed Medical Devices (3.0MB)
  • 02_Latest Regulatory Trends for Programmed Medical Devices (YouTube video)
  • 03_Approval Review of Programmed Medical Devices 2024 (4.8MB)
  • 03_Approval Review of Programmed Medical Devices 2024 (YouTube Video)
  • 04_Current Status and Challenges of Digital Health -Pharmaceutical Companies' Efforts - (1.4MB)
  • 04_Current Status and Challenges of Digital Health -Pharmaceutical Companies' Approach- (YouTube Movie)
  • 05_Current Status and Considerations in Digital Therapy (DTx) Development(0.9MB)
  • 05_Current Status and Points to Consider in Digital Therapy (DTx) Development(YouTube Movie)
  • 06_Q&A Session (266KB)
  • 06_Q&A Session (YouTube Movie)
  • 07_Closing Remarks(YouTube Movie)
  • Batch playback of videos (YouTube video)

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