27 October, 2006 Friday
0900- Discovery and development of diagnostic tools:
Necessity assessment, Principles and technology selection
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan
Prototype production and assessment
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan
Scale-up, manufacture and control
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan
Scale-up, manufacture and control (Cont.)
Development of kits
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan
Quality assurance/quality control: evaluation of efficacy after application
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan
Clinical development: validate prototype, manufacture pilot
lot, initiate clinical trial
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan
-1730 Clinical development: Supply chain logistics and production, Statistical consideration, regulatory issues
Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan