The mission of this conference is to address pressing issues for Phase O/I Trial Design especially in regards to use of predictive models, exploratory INDs, and regulatory and strategic recommendations. The FDAs Critical Path report defines the need to improve the drug development process and to increase predictability and efficiency. Part of the Critical Path initiative includes the FDAs recently released guidance on Exploratory INDs. The challenge is no longer to have a large quantity of compounds entering into Phase I studies; rather it is to increase the quality of the compounds.
This conference is designed for pharmaceutical, biopharmaceutical, biotech, CROs, sites and other industry professionals working in Phase O/I trial design.
Please visit www.iirusa.com/phase01 for more information and to register.