Regulatory Affairs Specialization

Regulatory Affairs

MACPR core curriculum

All MACPR students will complete the following core courses to build a solid foundation in the theory and conduct of clinical/preclinical research.

Nursing 7781
Responsible Conduct of Research
Nursing/Pharmacy 7770
Fundamentals of Medical Product Development and Regulation
Nursing/Pharmacy 7782
Research Design and Methods for Clinical and Preclinical Research
Nursing/Pharmacy 7405
Management of Clinical and Preclinical Studies
Pharmacy 7784
Data Analysis and Interpretation in Clinical and Preclinical Research
Pharmacy 5010*
Fundamentals of Pharmacology
*Pharmacology is required only for students without prior pharmacology coursework at the graduate or upper undergraduate level.

 

Regulatory Affairs Specialization coursework

In addition to the core coursework, students in the Regulatory Affairs Specialization will complete the following courses:

Required specialization courses:
 
Nursing/Pharmacy 7460
Regulatory Strategy, Writing, and Leadership
Pharmacy 7570
Pharmaceutical Safety & Risk Management
Nursing 7482

Principles of Quality Management for Medical Product Development

Pharmacy 7572
Federal Regulation of Medical Products
Nursing/Pharmacy 7599
Capstone in Applied Clinical and Preclinical Research
 
Select one of the following:
 
Nursing 7481
Data Management and Informatics in Clinical Research
Pharmacy 7580
Principles of Safety Pharmacology