Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 1: Introduction (2021)

Course Syllabus/Topics

1. Introduction
a. A big welcome to attendees from industry, academia, APEC, MPTX classes, etc.!
2. SC CTSI Clinical Research Support (CRS)
a. A comprehensive service aiding investigators and research teams to develop, activate, conduct, and report results for human subject research studies
3. Monitoring Module: https://uscregsci.remotelearne...
a. Created by the USC Department of Regulatory and Quality Sciences
b. To cross train investigators in the practices of monitoring 
4. Georgia CTSA and SC CTSI: Online Course Catalog
a. Link: https://twd.ce.emorynursingexp...
b. Offers free trainings for clinical research workforce to the first 400 registrants
c. Contact hours can be used for CRP certification renewal
5. For more information about the USC Regulatory and Quality Sciences, see the following link:
6. Degree Programs
a. Five Graduate Programs: DRSC, MS Regulatory Science, MS Management for Drug Development, and MS Medical Product Quality
b. Certificates: Food Safety, Regulatory Science, Early Drug Development, Clinical Design and Management, Patient and Product Safety
7. Symposiums
a. Occurring since 2015!
b. Symposium recordings are easily accessible for viewing on the SC CTSI’s online educational library: 
c. Topics for future symposia are from your feedback
8. Why Medical Devices?
a. Medical Devices Market has been steadily increasing; About 50% of pharmaceutical sales
b. Top 3 Worldwide Device Sales: InVitro Diagnostics, Cardiology and Diagnostic Imaging
c. Over 50,000 studies conducted involving medical device according to
d. Clinical trials for medical devices occur all around the world, emphasizing the need for harmonization of standards
9. Agenda
10. Program Evaluation
a. Please complete the evaluation at the end of the symposium to receive your certificate.
11. Time for Polls!


Accompanying text created by Annie Ly | Graduate Student, Regulatory Science, USC School of Pharmacy


Eunjoo Pacifici, PharmD, PhD
Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.