Module 4: Diagnostic Development

25 October, 2007   Thursday

0900- 1530     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

               Clinical development: Supply chain logistics and production, Statistical   consideration, regulatory issues

                         Dr. Masato Sasaki, Roche Diagnostics KK, Tokyo, Japan

1600-1700      Herbal medicine to modern medicine in China

                       Dr. Luping Qin, Shanghai, PRC


Course Agenda top  Back  Next