Module 4: Diagnostic Development

August 30, Tuesday (Day 7)

Describe the process of discovery and development of diagnostic tools

09:00-09:30 Discovery and development of diagnostic tools
Dr. Masato Sasaki, QIAGEN, Japan
09:30-10:00 Prototype production and assessment
Dr. Masato Sasaki, QIAGEN, Japan
10:00-10:30 Scale-up, manufacture and control
Dr. Masato Sasaki, QIAGEN, Japan
10:30-10:45 Break
10:45-11:15 Development of kits
Dr. Masato Sasaki, QIAGEN, Japan
11:15-11:45 Quality assurance/quality control: evaluation of efficacy after application
Dr. Masato Sasaki, QIAGEN, Japan
11:45-13:00 Lunch
13:00-13:30 Clinical development: validate prototype, manufacture pilot lot, initiate clinical trial
Dr. Masato Sasaki, QIAGEN, Japan
13:30-14:00 Clinical development: Supply chain logistics and production, Statistical
Dr. Masato Sasaki, QIAGEN, Japan
14:00-15:00 Rev and Exam 4 (Module 4)
Professor Dr. Kenji Hirayama and Professor Dr.Kesara Na-Bangchang


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