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Graduate Certificate in Drug Safety and Pharmacovigilance

Graduate Certificate in Drug Safety and Pharmacovigilance

photo of Kristen Mandello, who teaches in the Graduate Certificate in Drug Safety and Pharmacovigilance

I have a passion for safeguarding human and animal health. I have more than a decade of global vigilance experience, and I am committed to working to develop creative solutions to efficiently meet global compliance standards and surveillance needs.

Kristen Mandello

Overview

This innovative program prepares the student for working in the highly regulated medical industry in the specialized area of Drug Safety or Pharmacovigilance.

Upon completion of the Drug Safety and Pharmacovigilance certificate program, students will be able to:

  • Be knowledgeable in laws, regulations, and guidelines related to drug safety and pharmacovigilance principles
  • Outline the product development process for medical products
  • Locate information necessary in their role as drug safety and pharmacovigilance professionals
  • Describe the pre-approval and approval requirements for the safety of new products, including the maintenance of those products after marketing through pharmacovigilance systems
  • Be familiar with the complex interaction between regulatory requirements and development processes for new products.
  • Apply established principles of the submission process that regulatory authorities use to evaluate new medical product applications Be familiar with safety signal monitoring and detection technologies

Accreditations

The University of Georgia is accredited by the Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) to award baccalaureate, master’s, specialist, and doctoral degrees. The University of Georgia also may offer credentials such as certificates and diplomas at approved degree levels. Questions about the accreditation of the University of Georgia may be directed in writing to the Southern Association of Colleges and Schools Commission on Colleges at 1866 Southern Lane, Decatur, GA 30033-4097, by calling (404) 679-4500, or by using information available on SACSCOC’s website (www.sacscoc.org).

College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE).

Other online programs of interest

You also may be interested in these online programs:

Master of Science (M.S.) in Pharmacy, International Biomedical Regulatory Sciences

Graduate Certificate International Biomedical Regulatory Sciences

Graduate Certificate Clinical Trials Design and Management

Graduate Certificate in Chemistry, Manufacturing & Controls

Admissions

Credit and Transfer

Total Hours Required to Earn a Graduate Certificate in Drug Safety and Pharmacovigilance:  17 (credit hours)
Maximum Hours Transferable into Program:  N/A

Drug Safety and Pharmacovigilance Admission Requirements

Students who are not currently enrolled at UGA should apply to the graduate school for the Graduate Certificate program in Drug Safety and Pharmacovigilance and are not required to take entrance exams and submit letters of recommendation. Preference will be given to applicants with a degree in sciences, healthcare, or engineering.  Preference will also be given to applicants employed in the pharmaceutical, medical device, and biotechnology industries, or related fields.

Applying to the Certificate in Drug Safety and Pharmacovigilance Program is a two-step process. You will need to submit our departmental application and an application to the UGA Graduate School.

Application Checklist

  1. Application – Submit online to the Graduate School Admissions. Application fee: $75 Domestic/ $100 International
  2. Select Campus – Online 
  3. Select Intended Program – CERG, Drug Safety and Pharmacovigilance (College of Pharmacy) [CERT_2DSP] 
  4. Submit the Supplemental Application Certificate in Drug Safety & Pharmacovigilance Application (pdf) – Complete and email to regsciences@uga.edu or mail to the department:
    Regulatory Affairs Graduate Education Program
    The University of Georgia Gwinnett Campus
    2530 Sever Road
    Lawrenceville, Georgia 30043-4005
  5. Résumé or curriculum vita – Upload to the Graduate School application.
  6. Statement of Purpose – Submit to the Graduate School online in your application  
  7. Transcripts – Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission. 
  8. Letters of Recommendation – Submit two letters of recommendation online to graduate school. Letters should be from individuals who can evaluate the applicant’s scholarly ability and potential for success in a graduate program. The application will prompt your recommenders to submit their letters electronically.

International Applicants – must also submit TOEFL or IELTS scores.

Application Deadlines

Domestic Applicants

  • Fall:  June 1
  • Spring: November 1

International Applicants

  • Fall:  April 15
  • Spring: October 15

Cost

Tuition rates and student fees can change each year. 

Based on credit hour cost, a person completing this program at the recommended pace would pay $12,240 in tuition.  

Please use the Estimated Cost Calculator on the Bursar’s Office website to calculate one academic (Fall/Spring) year’s current tuition. 

This program is an E-Rate program, so choose “yes” for the E-Rate line item within the calculator.

Online students pay the following fees: Connect UGA, Green, and Technology. The total for those fees in the fall semester of 2022 was $147 for students enrolled in exclusively online courses. 

Potential additional costs include textbooks, exam proctoring fees, and technology upgrades. 

The complete cost of attendance can be found at https://osfa.uga.edu/costs/.

Financial Aid

Visit the Office of Student Financial Aid for information about financial assistance.

Corporate Assistance

Consult your employer about the availability of tuition reimbursement or tuition assistance programs.

Military Assistance

Active duty military, veterans, and military families should visit Veterans Educational Benefits to take full advantage of available financial assistance and educational benefits.

University System of Georgia Tuition Assistance Program (TAP)

The purpose of TAP is to foster the professional growth and development of eligible employees. For more information, see Tuition Assistance (refer to the Distance Learning section). 

Technology Requirements

  • Computer with current operating system (Windows, Mac, or Linux). Additional peripherals such as webcam, headphones, and microphone are required.
  • High-speed internet access.

Curriculum

Drug Safety and Pharmacovigilance Program Structure

The program plan is ideal for working professionals and consists of 17 semester credit hours, delivered online.

Courses

CourseTitleCredit
PHAR 6010EPharmaceutical, Biotechnology,
and Device Industries
4
PHRM 7230EEthical Issues in Research3
PHAR 6140EOverview of Drug Safety
Throughout Medical Product
Lifecycle
4
PHAR 6310EGood Clinical Practice Regulations
for Drugs, Biologic Products, and
Medical Devices
3
PHAR 7100EBiostatistical Applications for
Pharmaceutical and Biotechnology
Industries
3

Faculty

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Contact Information

Contact us using the request for information form or call 706-542-7948.

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