In general, vaccine is a preventive medicine and effective for infectious diseases, therefore it is necessary to do the benefit/risk (B/R) assessment under different points of views from ordinal medicines for therapeutic use. The B/R assessment of vaccine is important for decision making in all steps, development, approval and usage. To adapt various decision making, it is required that B/R assessment should be done on not only medically aspects but also socially, economically and ethically aspects including using health technological assessment (HTA) which was officially decided to introduce in Japan. It is also necessary that the faster vaccine development and approval to confront new pandemics by using new technologies such as newly vaccine productions and appropriate new adjuvants. As a part of international contribution of Japan, it is made various efforts to provide vaccine to developmental countries using public-private partnership since vaccine is one of effective tools for prevention of infectious diseases especially in these countries. It is important that development of innovative vaccine using new formulation which allows vaccinating in less medical environment places. Thus establishment of new decision standard and flexible B/R evaluation will be needed in addition to empirically assessment. We would like to have this international lecture symposium to discuss future vaccine development with sharing various knowledges including different regulatory framework and B/R assessment in foreign countries from Japan.
If you have time, please join the lecture symposium. You will learn something new.
Professor Katsura Tsukamoto, PhD Assistance Professor Naoki Matsumaru, PhD Visiting Professor Toichi Takenaka, PhD Global Regulatory Science, Gifu Pharmaceutical University