Vigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects resulting from the use of a therapeutic product. This unit will cover the identification and quantification of risk associated with medicinal products, recognition, and interpretation of adverse effects and their underlying toxicopathology and pharmacology. Students will learn to write and interpret several documents associated with product vigilance including Risk Management Plans (RMPs), Periodic BenefitRisk Evaluation Report (PBRER), Development Safety Update Reports (DSURs). The international and Australian guidelines for adverse event reporting and the role of the qualified person and compliance will be addressed in the course.
Unit details and rules
Academic unit | Pharmacy |
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Credit points | 6 |
Prerequisites
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None |
Corequisites
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None |
Prohibitions
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None |
Assumed knowledge
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None |
Available to study abroad and exchange students | No |
Teaching staff
Coordinator | Orin Chisholm, orin.chisholm@sydney.edu.au |
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Tutor(s) | Philip Kwok, philip.kwok@sydney.edu.au |