Durham, North Carolina
5th December 2019
Registration will open in November.
All PhUSE Single Day Events are FREE to members. To become a member click here. Registrations per company are limited to 20% of maximum attendance.
New Pathways to Approval
New pathways to approval – study/program designs that use methodologies other than traditional Phase I to III randomized trials. The FDA recently published a guidance about this, encouraging sponsors to use non-traditional approaches such as master protocols, basket protocols, continuous drug development and historical cohorts instead of placebo.
Jeff Abolafia, Rho
Ramesh Ayyappath, ICON
If you have any questions, or require any information, please contact one of the SDE Chairs.
If you are interested in sponsoring this event, click here.
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