Regulatory Science Symposium: Patient-Centered Drug Development and Real World Evidence/Data Session 7: Wrap-up (2019)

1. Monitoring Module & Clinical Research Professional Training
2. University of Southern California and Food and Drug Administration Resources
3. Patient Experience Data Role in Product Development and Decision Making
4. 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:
   7. Please share your experiences and/or thoughts related to this bootcamp and ask any questions you have!

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