Module 3: Vaccine Development

October 17, Saturday (Day 4)

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

15:00-15:30 Historical overview of vaccine Discovery
Professor Dr. Kenji Hirayama, Nagasaki University, Japan
15:30-16:30 Vaccines for infection control
Professor Dr. Kenji Hirayama, Nagasaki University, Japan

October 18, Sunday (Day 5)

09:00-10:00 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

10:00-10:30 CMC
Dr. Takeshi Arakawa, University of the Ryukyus, Japan
10:30-11:00 Immunogenicity and protect activity assessment
Dr. Takeshi Arakawa, University of the Ryukyus, Japan
11:00-11:45 Safety assessment:Toxicity test in animals: regional complications, systemic toxicity
Dr. Takeshi Arakawa, University of the Ryukyus, Japan
11:45-13:00 Lunch

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

13:00-14:00 Assessment of pre-clinical information
Dr.daisuke tsuzuki
14:00-14:30 Clinical development plan
Dr.daisuke tsuzuki
14:30-15:30 Dose selection and regimen
Dr.daisuke tsuzuki
15:30-16:30 Case studies
Professor Dr. Kenji Hirayama, Nagasaki University, Japann
16:30-17:30 Rev and Exam 3 (Module 3)s
Professor Dr. Kenji Hirayama, Nagasaki University, Japan

October 19, Monday (Day 6)

10:00-17:00 Field Trip to Hisamitsu Pharmaceutical Co.,Inc
Mr.Hideyuki Nakano,Hisamitsu Pharmaceutical Co.,Inc


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