By: Ellie Shafer, student in CoP Marketing & Communications
The College of Pharmacy’s International Biomedical Regulatory Sciences program now offers two new, online certificates – one in Drug Safety and Pharmacovigilance and the other in Chemistry, Manufacturing and Controls (CMC).
“These new graduate certificate programs add to the depth of our already stellar IBRS curriculum,” said Dr. Michael G. Bartlett, University Professor and Associate Dean for Science Education, Research and Technology at the College. “With the advent of these innovative training programs, we are preparing students to succeed in the highly regulated medical safety and medical product industries.”
IBRS faculty and staff work cooperatively with UGA’s Office of Online Learning to administer these certificate programs. The following outlines the requirements and details of the two new IBRS certificates:
Drug Safety and Pharmacovigilance Certificate
Designed for graduate students and working professionals interested in working in the Drug Safety and Pharmacovigilance industry, the certificate requires 17 credit hours of online classes, which include:
- PHAR6010E: Overview of the Pharmaceutical, Biotechnology, Animal Health and Device Industries (4 semester hours)
- PHRM7230E: Introduction to Bioethics (3 semester hours)
- PHAR7100E: Biostatistical Applications for Pharmaceutical & Biotechnology Industries (3 semester hours)
- PHAR6140E: Overview of Drug Safety Throughout Medical Product Lifecycle (4 semester hours)
- PHAR6310E: Good Clinical Practice (3 semester hours)
Students who complete the Drug Safety and Pharmacovigilance certificate will gain knowledge in laws, regulations, and guidelines related to drug safety and pharmacovigilance principles; be versed in the pre-approval and approval requirements for the safety of new products; be familiar with the complex interaction between regulatory requirements and development processes for new products; and more.
International applications are due April 15, with domestic applications due June 1.
The Chemistry, Manufacturing, and Controls (CMC) certificate
Delivered online, the CMC certificate also is designed for graduate students and working professionals with an interest in Chemistry, Manufacturing, and Controls. The online certificate is 14 credit hours that can be completed in three semesters. The following are the courses:
- PHAR6030E: Current Good Manufacturing Practices (4 semester hours)
- PHAR6160E: Chemistry, Manufacturing and Controls (4 semester hours)
- PHAR6100E: Quality Control and Quality Assurance (3 semester hours)
- PHAR6120E: Process Control and Validation (3 semester hours)
Upon completion of the certificate, students will be competent in laws, regulations, and guidelines regarding drug approval requirements; understand Good Manufacturing Practices and Quality Design, and be able to outline the product development process for medical products, among other skills.
Domestic applications for this program are due June 1, while international applications are due April 15.