Module 3: Vaccine Development

November 2, Friday (Day 5)

Session 1: Discovery
Describe the principles of basic immunology. Describe the process of vaccine discovery

09:00-09:30 Historical overview of vaccine Discovery
Professor Dr. Kenji Hirayama, Nagasaki University, Japan
09:30-10:30 Vaccines for infection control
Professor Dr. Kenji Hirayama, Nagasaki University, Japan
10:30-10:45 Break
10:45-12:15 Vaccines for infection control
Professor Dr. Kenji Hirayama, Nagasaki University, Japan
12:15-13:30 Lunch
13:30-14:30 Vaccine Platform Technology and Adjuvant Development
(Dr.Arakawa)
Dr. Takeshi Arakawa, University of the Ryukyus, Japan

Session 2: Pre-Clinical Development
Describe the process of pre-clinical development of vaccine

14:30-15:00 CMC
Dr. Takeshi Arakawa, University of the Ryukyus, Japan
15:00-15:15 Break
15:15-15:45 Immunogenicity and protect activity assessment
Dr. Takeshi Arakawa, University of the Ryukyus, Japan
15:45-16:30 Safety assessment:Toxicity test in animals: regional
complications, systemic toxicity
Dr. Takeshi Arakawa, University of the Ryukyus, Japan

November 6, Tuesday (Day 7)

Session 3: Clinical Development
Describe the process of vaccine clinical development

09:00-10:00 Assessment of pre-clinical information
Dr.Daisuke Tsuzuki, Sanofi Pasteur KK. Tokyo, Japan
10:00-10:30 Clinical development plan
Dr.Daisuke Tsuzuki, Sanofi Pasteur KK. Tokyo, Japan
10:30-10:45 Break
10:45-11:45 Dose selection and regimen
Dr.Daisuke Tsuzuki, Sanofi Pasteur KK. Tokyo, Japan
11:45-13:30 Lunch
13:30-15:45 Case studies
Professor Dr. Kenji Hirayama, Nagasaki University, Japan
15:45-16:00 Break
16:00-17:00 Rev and Exam 3 (Module 3)
Professor Dr. Kenji Hirayama, Nagasaki University, Japan


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