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UNIVERSITY OF GEORGIA
(Georgia)

Master of Science in Pharmacy with an emphasis Regulatory Affairs

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SPECIFIC SCHEDULE
What is the specific time to complete the program?
Must required courses be taken in a specific order?

All newly admitted students are required to first take the PHAR 6010 course, Introduction to Pharmaceutical, Biotechnology, and Medical Device Industries: A Regulatory Overview. Upon completion of that course, then they can take other required and elective courses, but this is the course with which they must start.

Program is part-time only. Students generally take one to two courses in a given semester. There is no time limit on completion of the program. However, the UGA Graduate School has a policy on Continuous Enrollment. Beginning Fall Semester 2007, the Continuous Enrollment Policy of the Graduate School begins. Essentially, the policy is that degree-seeking graduate students must register for a minimum of three (3) hours for at least two (2) semesters in each academic year (Fall, Spring, Summer). This policy takes effect Fall Semester 2007 for all graduate students except the following: University employees on the Tuition Assistance Program; and, Students in non-degree status As you plan your studies at the University of Georgia, please become familiar with the policy in the Graduate Bulletin at the website.
PROJECTED SCHEDULE OF PROPOSED OFFERINGS FOR PERIOD OF DEGREE PROGRAM (BY TERM)
Master of Science in Pharmacy with an emphasis in Regulatory Science (37 sem hrs)

Core (22 semester hours):
Completion of Certificate Courses (13 semester hours)
PHAR 6010 Pharmaceutical, Biotechnology, and Device Industries (4 sem hrs)
PHAR 6020 Food and Drug Law (3 sem hrs)
PHAR 6030 Current Good Manufacturing Practices (4 sem hrs)
PHRM 7230 Ethical Issues in Research (2 sem hrs)

PHAR 6010 - Fall and Spring Semesters; PHAR 6020 - Fall and Summer Semesters; PHAR 6030 - Summer and Spring Semesters; and PHRM 7230 Fall and Spring Semesters; All other courses are scheduled based on student need.

Additional Core Courses (9 semester hours):
PHAR 6100 Quality Control and Quality Assurance (3 sem hrs)
PHAR 6120 Process Control and Validation (3 sem hrs)
BIOS 7100 Biostatistical Applications for Pharmaceutical & Biotech Industries (3 sem hrs)

Electives (minimum of 9 semester hours):
Program Electives (must complete at least 6 semester hours of program electives)
Regulatory Affairs for the Pharmaceutical Industry (2 sem hrs)
Regulatory Affairs for the Biotechnology Industry (2 sem hrs)
Regulatory Affairs for the Medical Device Industry (2 sem hrs)
Clinical Trials Management (3 sem hrs)
Critical Issues in Regulatory Sciences (3 sem hrs)
Topics vary: In-depth analysis of major regulatory issue or regulated industry (e.g., Animal Health Products, Combination Products)
Comparative Global Regulations (3 sem hrs)
Internship in Regulatory Affairs (3 sem hrs)
PHRM 6800 Applied Project in Regulatory Affairs (3 sem hrs)

Other Electives: (* = with approval by home department)
PHRM 8660 Health Care Marketing (3 sem hrs)
*MGMT 7010 Developing Leadership Skills (1-3 sem hrs)
*MGMT 7220 Project Management (3 sem hrs)
*SPCM 6610 Health Communication (3 sem hrs)

Thesis (6 semester hours):
The master's thesis is either a basic or applied research project conducted by the student supervision of the student's advisory committee. A final oral examination is required.
PHRM 7000 Masters Research (3 sem hrs)
PHRM 7300 Masters Thesis (3 sem hrs)
ADDITIONAL SCHEDULE INFORMATION
The program is not self-study, nor done at a self-paced format. The Masters program operates on a traditional academic calendar (the semester system) and traditional academic processes (such as admissions criteria and processes; as well at course tests, quizzes, papers, with due dates, etc). Where we differ is in the mode of delivery. We offer our program via the web using a course management system called WebCT. Furthermore, we are geared to the adult learner and therefore we have set up our program to be done on a part-time basis (generally, one to two classes at a time).

Students considering our program should be disciplined and self-directed in order to be successful in our program. Students are required to keep up with the course work and its deadlines. To view some sample course syllabi, select this link:
http://www.rx.uga.edu/main/home/reg_affairs/program_description.htm.

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