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Regulatory Science/The Science Board/Standard Development

The 34th Science Board Meeting

Press Release

Date and Time: October 7, 2019 from 3pm to 5pm

Agenda / List of Handouts

Agenda
  1. Lecture and Exchange of Opinions on Microbiome
    • Gut Microbiota in Health and Disease (Dr. Kiyoshi Takeda, Director / Professor, WPI Immunology Frontier Research Center, Osaka University)
    • Intestinal Microbiota Metabolites and Disease / Bioprotection (Dr. Hiroshi Ohno, Team Leader, Laboratory for Intestinal Ecosystem, RIKEN Center for Integrative Medical Sciences)
  2. Clinical Trials of Live Microbiome-based Products (Viable Bacterial Preparations)
  3. Others
List of Handouts
  • Document 1 Lecture Materials (Dr. Kiyoshi Takeda, Director / Professor, WPI Immunology Frontier Research Center, Osaka University)
  • Document 2 Lecture Materials (Dr. Hiroshi Ohno, Team Leader, Laboratory for Intestinal Ecosystem, RIKEN Center for Integrative Medical Sciences)
  • Document 3 Clinical Trials of Live Microbiome-based Products (Viable Bacterial Preparations)
  • Ref.1 Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (FDA:Guidance for Industry) https://www.fda.gov/media/82945/download