Pharmaceutical Regulatory Science

LINKS

This half-year course includes lectures and 2 sets of debates and group discussion. This course aims at an audience of government regulators, pre-clinical and clinical researchers in industry and institutions, and industrial managers in R&D. The objective of this course is to provide attendees with up-to-date knowledge on global guidelines, statistics and data management methodology, difficulties in efficacy/safety evaluation, and other topics that are of importance for efficient drug development and evaluation.

RC Debate and Group Discussion

RC consists of both lectures and group dicsussion followed by debates.
Discussion subjects would be presented to RC attendees, who would discuss the matter within their group. After presenting their solutions, the group would have a debate with an opposing group. These sets of multi-displinary discussion and debate has been gaining favorable comments from past attendees.

Examples of discussion subjects

Explain the issues that Japanese citizens are facing, regarding development, approval and provision of the H1N1 swine flu vaccine.
Then, discuss the possible strategies that could be taken, in perspectives of
(a) The Minister of MHLW (Minsitry of Health Labour and Welfare)
(b) The CEO of a drug company with an ongoing project of H1N1 swine flu vaccine
and critically evaluate the current status of the MHLW or drug company.

• Graduate School Lectures
• RC (Regular Course)
• IC (Intensive Course)