Pmda - Pharmaceuticals and Medical Devices Agency

Regulatory Science/The Science Board/Standard Development

The 4th Bio-products Subcommittee Meeting

Press Release

(Joint Meeting with the Pharmaceuticals Subcommittee)
Date and Time: May 10, 2013  from 6pm to 8pm

Agenda / List of Handouts

  1. Personalized medicine
    1. (1) Direction and method of future discussion
    2. (2) Scope and positioning of biomarker endpoint
  2. Others
List of Handouts
  • Document 1 Direction and method of discussion in the joint meeting of the Pharmaceuticals and Bio-products Subcommittees (draft)
  • Document 2 Biomarker
  • Document 3 Using biomarker in pharmaceutical development
  • Ref. Examples of biomarkers used for clinical evaluation (therapeutic medicine for osteoporosis)