Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 1: Introduction (2019)

1. Introduction
2. Audience polling
   1. How would you describe yourself?
   2. In which of the following types of studies are you involved?
   3. Where are you from?
   4. Are you funded by a CTSA Hub?
   5. What is your knowledge of patient-centered drug development?
   6. Have you ever worked on a clinical trial using real world evidence/data?
   7. What learning do you hope to take away from today?
3. SC CTSI Clinical Research Support (CRS)
4. Monitoring module
5. Establishing monitoring pool at USC
6. Five Graduate Programs in Regulatory Sciences at USC
7. Boot camp agenda
8. Audience polling
   1. What does the term patient-centered drug development refer to?
   2. What was the primary goal of patient-centered drug development?
   3. What is the purpose of the Orphan Drug Act (ODA)?
   4. Select all answers applicable to rare diseases:
   5. The following types of data classify as “real-world”:
   6. Translational research is/are which of the following:

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu