33 hours

Three Letters of recommendation CV/resume Statement of Purpose (emphasizing goals and objectives) Professional or Academic Writing Sample Official transcript (3.0 minimum G.P.A.) Department Interview For students whose primary language is not English, proof of English proficiency is required. Students need to submit official university documents according to the UGA Graduate School requirements. Application deadlines: Domestic Applicants: Fall - June 1 and Spring - November 1 International Applicants: Fall - April 15 and Spring - October 15 No new admissions for Summer Semester

BIOS(PHAR) 7100E

Biostatistical Applications for the Pharmaceutical and Biotechnology Industries

3

PHAR 6010E  *

Pharmaceutical, Biotechnology, and Device Industries

4

PHAR 6020E  Analytical Thinking

Food and Drug Law

3

PHAR 6030E  Analytical Thinking

Current Good Manufacturing Practices

4

PHAR 6130E

U.S. Marketing Applications for New Drugs, Biologics, and Medical Devices

4

PHRM(HPAM) 7230E

Ethical Issues in Research

3

*This is a prerequisite course for all IBRS courses except for PHRM(HPAM) 7230E and BIOS(PHAR) 7100E.

Non-Thesis Track

PHAR 6950E  (3 hours)

Master's Seminar in Regulatory Affairs

1-6

Choose 1 course(s) from the following:

PHAR 6800

Applied Project in Regulatory Affairs

3

PHAR 6900  (3 hours)

Internship in Biomedical Regulatory Affairs

1-4

Thesis Track

PHRM 7300  (6 hours)

Master's Thesis

1-15

Choose 6 credit hour(s) from the following:

PHAR 6100E  Analytical Thinking

Quality Control and Quality Assurance

3

PHAR 6120E  Analytical Thinking

Process Control and Validation

3

PHAR 6140E

Overview of Drug Safety Throughout Medical Product Lifecycle

4

PHAR 6160E  Analytical Thinking

Chemistry, Manufacturing, and Controls

4

PHAR 6180E

Animal Health Regulatory

4

PHAR 6200E

Clinical Trials Design and Management

4

PHAR 6210E

Project Management in Clinical Trials

3

PHAR 6310E  Analytical Thinking

Good Clinical Practice Regulations for Drugs, Biologic Products, and Medical Devices

3

PHAR 6340E

European Pharmaceutical and Biologics Regulatory Sciences

3

PHAR 6360E

Latin American Pharmaceutical and Biologics Regulatory Sciences

3

PHAR 6380E

Global Medical Device Regulatory Submissions - The Marketing Application Process

3

Graduates generally have careers in regulated pharmaceuticals, medical devices, or biotechnology industries. Others will find career opportunities in government agencies, academic institutions, clinical research organizations, hospitals or healthcare organizations.

A maximum of 6 credits may be transferred into the program with the Director’s approval as long as the credit hours have not been used to fulfill another degree program.

Students are encouraged to seek internships for professional growth. The department does not offer internships directly. Those interested in pursuing internships must do so independently and should contact the department for guidance on seeking academic credit for their internship.

Students are encouraged to present their research at conferences, professional meetings, and symposia.

Other graduate programs in the College of Pharmacy include: Pharmacy (M.S.) - Emphasis in Clinical Trials Management Pharmacy (M.S.) - Emphasis in Clinical and Experimental Therapeutics Pharmacy (Ph.D.) - Emphasis in Clinical and Experimental Therapeutics Pharmacy (M.S.) - Emphasis in Pharmaceutical Health Services, Outcomes, and Policy Pharmacy (Ph.D.) - Emphasis in Pharmaceutical Health Services, Outcomes, and Policy Pharmacy (Ph.D.) - Emphasis in Pharmaceutical and Biomedical Sciences Toxicology (Ph.D.)