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Unit of study_
PHAR7825: Therapeutic Product Vigilance
2024 unit information
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
Managing faculty or University school:
Medicine and Health
| Study level | Postgraduate |
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| Academic unit | Pharmacy |
| Credit points | 6 |
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Prerequisites:
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None |
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Corequisites:
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None |
| Prohibitions:
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None |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. Understand the requirements for post-marketing compliance and product vigilance activities and their contribution to the safety of a therapeutic product
- LO2. Analyse risks of therapeutic products
- LO3. Perform activities associated with the role of the vigilance and product safety specialist
- LO4. Integrate knowledge, skills and experience of product vigilance and risk profiles using reflective practice
Unit availability
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Modes of attendance (MoA)
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