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Regulatory Science/The Science Board/Standard Development

The 2nd Subcommittee on CPC (Cell Processing Center)

Press Release

Date and Time: September 16, 2014  from 4pm to 6pm

Agenda / List of Handouts

Agenda
  1. Issues to Discuss
  2. Concept of GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice)
  3. GCTP in CPC- Focusing on Sterility -
  4. Others
List of Handouts
  • Document 1 Issues to Discuss in the Future CPC Subcommittee (draft)
  • Document 2 Concept of GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice)
  • Document 3 Three Regulation and Ordinances on Cellular and Tissue-based products; "Regulations for Buildings and Facilities for Pharmacies," "Ministerial Ordinance on Good Gene, Cellular and Tissue-based Products," "Ministerial Ordinance on Good Quality Practice for Drugs, Quasi Drugs, Cosmetics and Cellular and Tissue-based Products"
  • Document 4 Material Submitted by Dr. Masahiro Kinooka, a Member of the Subcommittee
  • Document 5-1 Material Submitted by Dr. Tomohiro Morio, a Member of the Subcommittee
  • Document 5-2 Material Submitted by Dr. Tomohiro Morio, a Member of the Subcommittee(official release version of the material 5-1)