October 19, Wednesday (Day 8)
Objective: To describe the process of discovery and development of diagnostic tools
9:00-10:00 Discovery and development of diagnostic tools
Dr. Masato Sasaki, QIAGEN, Japan
10:00-10:30 Prototype production and assessment
Dr. Masato Sasaki, QIAGEN, Japan
10:30-10:45 Tea break
10:45-12:45 Scale-up, manufacture and control
Dr. Masato Sasaki, QIAGEN, Japan
12:45-13:45 Lunch
13:45-14:45 Development of kits
Dr. Masato Sasaki, QIAGEN, Japan
14:45-15:00 Tea break
15:00-16:00 Quality assurance/quality control: evaluation of efficacy after application
Dr. Masato Sasaki, QIAGEN, Japan
16:00-16:30 Clinical development: validate prototype, manufacture pilot lot, initiate clinical trial
Dr. Masato Sasaki, QIAGEN, Japan
16:30-17:00 Clinical development: supply chain logistics and production,, Statistical consideration, regulatory issues
Dr. Masato Sasaki, QIAGEN, Japan
17:00〜 Review and exam (Module 4)
Professor Dr. Kenji Hirayama and Professor Dr. Kesara
Na-Bangchang