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Social and Administrative Sciences
Master
of Science Degree
with specialiation in Drug Regulatory Affairs
Drug
Regulatory Affairs is an exceedingly complex and growing
field of endeavor. Almost every operational component
of the pharmaceutical industry is strongly dependent
on having individuals with expertise related to the legal
and regulatory environment, as well as clinical research
protocols. The program is intended to help students gain
an understanding of and appreciation for the myriad Federal
statutes and regulations that control the drug-approval
process not only in the United States but worldwide.
Another aim of the program is to provide the stimulating
background for students to make the most of their capabilities
and to prepare them for a dynamic work environment in
which they will function more effectively.
Degree Requirements
Students
taking the Non-Thesis Option must complete 33 credits
of course work and pass the written Comprehensive Examination.
Students taking the Thesis Option must complete 33 credits
of course work of which 3 credits are for Research Methodology,
PHA 050, and 6 credits are for Research and Thesis, PHA
060. Thesis students must register for PHA 060 in two
consecutive semesters, 3 credits each semester.
| Required
Courses |
Cr. |
| PHA
010 |
Biostatistics |
3 |
| PHA
603 |
Drug
Regulatory Affairs |
3 |
| PHA
651 |
Pharmaceutical
Labeling, Advertising and Promotion |
3 |
| PHA
653 |
Seminar
in Social and Administrative Sciences |
3 |
| PHA
654 |
Regulation
of OTC Drugs, Medical Devices, Cosmetics, and Animal
Drugs |
3 |
| PHA
657 |
Principles
and Practices of Regulatory Compliance and Enforcement |
3 |
| PHA
660 |
Mechanics
of Preparing INDs and NDAs |
3 |
| PHA
661 |
Pharmaceutical
Industry |
3 |
|
24 |
| Electives
and Research |
Cr. |
| PHA
050 |
Research
Methodology* |
3 |
| PHA
060 |
Research
and Thesis* |
3 |
| PHA
601 |
Marketing
Research and Analysis |
3 |
| PHA
604 |
Pharmacoeconomics |
3 |
| PHA
607 |
Behavioral
Pharmacy |
3 |
| PHA
613 |
Marketing
Management |
3 |
| PHA
614 |
Health
Literacy |
3 |
| PHA
645 |
Internship
in Drug RegulatoryAffairs |
3 |
| PHA
655 |
Chemistry,
Manufacturing and Controls (CMC) Regulatory Affairs |
3 |
| PHA
656 |
Current
Enactments, Regulations and Guidelines |
3 |
|
|
9 |
| Total
Credits |
33 |
*Required
for students taking the Thesis Option.
In
consultation with the Division Director, students may
select electives from the graduate course offerings in
the Division of Social and Administrative Sciences and
the School of Business, Public Administration and Information
Sciences.
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