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Graduate Certificate in Drug Safety and Pharmacovigilance


Program Description

Geared toward a wide range of professionals, the Drug Safety and Pharmacovigilance Certificate Program provides a foundation for preparing candidates to lead and to manage all aspects related to drug safety as members of product development project team. Students will learn all aspects of managing Pharmacovigilance as members of commercial product stewardship team. Students will learn how to liaise with regulatory authorities to communicate and negotiate study protocols and label language related to safety. They will learn how to support management in due diligences and strategic business activities. They will learn how to work with IRB’s and data monitoring boards. There is special focus on FDA’s adverse event reporting systems and signal detection approaches for safety.

Contact

Director of Graduate Studies: Michael Bartlett, Professor mgbart@uga.edu 706-542-5390 Graduate Program Advisor/Graduate Program Administrator: Johnna Hodges jhodges@uga.edu 678-985-6808 https://rx.uga.edu/