Module 4: Diagnostic Development

November 5, Monday (Day 6)

Describe the process of discovery and development of diagnostic tools

09:00-10:00 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 Break
10:45-11:45 Scale-up, manufacture and control
Dr. Masato Sasaki, QIAGEN, Japan
11:45-12:30 Development of kits
Dr. Masato Sasaki, QIAGEN, Japan
12:30-13:45 Lunch
13:45-14:45 Quality assurance/quality control: evaluation of efficacy after
application
Dr. Masato Sasaki, QIAGEN, Japan
14:45-15:45 Clinical development: validate prototype, manufacture pilot lot,
initiate clinical trial
Dr. Masato Sasaki, QIAGEN, Japan
15:45-16:00 Break
16:00-16:30 Clinical development: Supply chain logistics and production,
Statistical
Dr. Masato Sasaki, QIAGEN, Japan
16:30-17:00 Rev and Exam 4 (Module 4)
Professor Dr. Kenji Hirayama and Professor Dr.Kesara
Na-Bangchang


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