14th DIA Japan Annual Meeting 2017

The ICH E17 guideline is expected to reach Step 4 in 4Q 2017. This session will provide an opportunity to discuss how to utilize E17 appropriately, where global development strategy move toward, and what can be done to induce a change in our strategy. We have experienced so many evaluations of consistent or similar results among ethnic groups under E5 guideline and we know how difficult evaluation of ethnic differences and consistency among ethnic groups are. Given those experiences, this session will also address the points to consider in planning a global development program by means of E17, newly introduced pooling strategies (pooled region, pooled subpopulation), what kind of information is need for pooling, when such information to be obtained, how to present results from the Multi-Regional Clinical Trials. Those discussions would contribute to your readiness for the paradigm shift in global development strategy.