REQUIRED COURSES
|
| RA 3200 | Biologics Development: A QA/Regulatory Overview | 4 q.h. |
| RA 3201 | New Drug Development: A QA/Regulatory Overview | 4 q.h. |
| RA 3202 | Medical Device Development: A QA/Regulatory Overview | 4 q.h. |
| | | |
CHOOSE ONE OF THE FOLLOWING COURSES
|
| RA 3203 | Food, Drug, and Medical Device Law: Topics and Cases | 4 q.h. |
| RA 3206 | Practical Aspects of Regulatory Compliance
| 4 q.h. |
| RA 3210 | Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets
| 4 q.h. |
| RA 3211 | Combination Products and Convergence
| 4 q.h. |
RA 3212
| Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devises in the U.S. and Abroad | 4 q.h.
|
| RA 3214 | Food and Drug Administration: Creation, Behavior, and Regulatory Culture
| 4 q.h. |
| RA 3216 | Medical, Social, and Financial Dimensions of Orphan Drugs | 4 q.h. |
| PW 3398 | Regulatory Writing: Medical Device Submissions
| 4 q.h. |
| PW 3399 | Regulatory Writing: New Drug Applications
| 4 q.h. |
| | | |
TOTAL QUARTER HOURS: 16
| |
