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UGA Reg Affairs General Course Schedules

Tentative Schedule for the Regulatory Affairs Program

The tables below provide a general outline of the schedule of courses for the UGA Regulatory Affairs Program by program of study and by semester.  Please use this information to help you plan your completion objectives.  These are general plans and therefore subject to change based on enrollment numbers, student needs and other factors. Always confirm the next semester's schedule with the RA Department or visit the Enrolled Students link.

| Schedule tables:  Master’s Program  |  Regulatory Affairs Certificate | Clinical Trials Certificate |

Important Points:
1) The UGA RA Department reserves the right to cancel any course that does not meet minimum enrollment of five students.  Even if a course is listed below, if at least 5 students are not enrolled, the Department may cancel this course.

2) Students should also remember that the UGA Regulatory Affairs Program is a part-time only program.  We cannot offer a full-time course selection. Bear this in mind as you think about your program of study and your time line.

3) Should a student require a course that is not offered in a given semester, please contact the Regulatory Affairs Department to discuss your specific needs or submit a request using our Online Course Request Form.

  • Use of this form is limited to UGA Students, either currently enrolled in RA courses or have been admitted into one of the RA programs.
  • Please limit your use of this form to ONE SEMESTER per online request. We want to know only your immediate course needs, not your entire program of study.

4) Master’s Students: The tables below do not contain information on -

  • PHAR 6800 (Applied Project);
  • PHAR 6900 (Internship);
  • PHAR 6950 (Masters Seminar);
  • PHRM 7000 (Master’s Research);
  • PHRM 7300 (Master’s Thesis)

These courses are offered only to Master’s students on an as-needed basis.  Master’s students should contact the Regulatory Affairs advisor for assistance with these independent study courses.

 

Master’s General Schedule

Program of Study:

Master’s Program (both Project and Thesis options)
(38 to 39 credit hours required)

Characteristics
(required or elective)

 

Fall Semester

PHAR 6010  Intro to Pharma, Biotech & Device Industries (4 c.h.)

Core - required

PHRM 7230 Ethics in Research (3 c.h.)

Core - required

PHAR 6120  Process Control & Validation (3 c.h.)

Core - required

PHAR 6320  Understanding the Role and Fxn of FDA  (3 c.h.)

Approved elective

Spring Semester

PHAR 6010  Intro to Pharma, Biotech & Device Industries  (4 c.h.)

Core - required

PHAR 6020  Food & Drug Law  (3 c.h.) or PHAR 6030 Current GMPs  (4 c.h.)
These courses generally alternate, one or the other.

Core - required

Core - required

PHRM 7230 Ethics in Research  (3 c.h.)

Core - required

PHAR 6100  Quality Control & Quality Assurance  (3 c.h.)

Core - required

PHAR 6130  FDA Applications & Submissions  (4 c.h.)

Core - required

PHAR 6200  Clinical Trials Design & Monitoring  (4 c.h.)

Approved elective

Summer Semester

PHAR 7100 Biostatistical Applications  
(3 c.h.)

Core - required

PHAR 6210 Project Management for Clinical Trials  (3 c.h.)

Approved elective

PHAR 6030 Current GMPs  (4 c.h.) or
PHAR 6020 FDA Law (3 c.h.)
These courses generally alternate, one or the other.

Core - required

*Reminder:  The UGA RA Department reserves the right to cancel any course that does not meet minimum enrollment numbers or for any other unforeseen event. 

** Reminder: If there is a UGA graduate-level course outside the department that the student wishes to take in lieu of an approved department elective, such as Health Care Marketing or Health Communication, the student will need to contact the department for prior approval.  The student should take into consideration that courses outside of the Regulatory Affairs Department are NOT necessarily distance learning courses.

| Schedule tables:  Master’s Program  |  Regulatory Affairs Certificate | Clinical Trials Certificate |

 

Regulatory Affairs Certificate General Schedule

Program of Study:

Regulatory Affairs Certificate
(14 credit hours required)

Characteristics

 

Fall Semester

PHAR 6010  Intro to Pharma, Biotech & Device Industries (4 c.h.)

Required

PHRM 7230 Ethics in Research (3 c.h.)

Required

Spring Semester

PHAR 6010  Intro to Pharma, Biotech & Device Industries  (4 c.h.)

Required

PHAR 6020  Food & Drug Law  (3 c.h.) or PHAR 6030 Current GMPs  (4 c.h.)
These courses generally alternate, one or the other.

Required

Required

PHRM 7230 Ethics in Research  (3 c.h.)

Required

Summer Semester

PHAR 6030 Current GMPs  (4 c.h.) or
PHAR 6020 FDA Law (3 c.h.)
These courses generally alternate, one or the other.

Required

*Reminder:  The UGA RA Department reserves the right to cancel any course that does not meet minimum enrollment numbers or for any other unforeseen event. 

**Reminder: RA Certificate students are limited only to the courses listed in RA Certificate Program of Study.

| Schedule tables:  Master’s Program  |  Regulatory Affairs Certificate | Clinical Trials Certificate |

 

Clinical Trials Certificate General Schedule

Program of Study:

Clinical Trials Certificate Path  (17 credit hours required)

Characteristics

 

Fall Semester

PHAR 6010  Intro to Pharma, Biotech & Device Industries (4 c.h.)

Required

PHRM 7230 Ethics in Research (3 c.h.)

Required

Spring Semester

PHAR 6010  Intro to Pharma, Biotech & Device Industries  (4 c.h.)

Required

PHRM 7230 Ethics in Research  (3 c.h.)

Required

PHAR 6200  Clinical Trials Design & Monitoring  (4 c.h.)

Required

Summer Semester

PHAR 7100 Biostatistical Applications  
(3 c.h.)

Required

PHAR 6210 Project Management for Clinical Trials  (3 c.h.)

Required

*Reminder:  The UGA RA Department reserves the right to cancel any course that does not meet minimum enrollment numbers or for any other unforeseen event. 

**Reminder: This program admits news students only one time per year, to start Fall Semester.

*** Reminder: CT Certificate students are limited only to the courses listed in CT Certificate Program of Study.

| Schedule tables:  Master’s Program  |  Regulatory Affairs Certificate | Clinical Trials Certificate |

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