Skip to main content
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:


Code PHAR7825
Academic unit Pharmacy
Credit points 6
Assumed knowledge:

The learning outcomes for this unit will be available two weeks before the first day of teaching.

Unit availability

This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.

The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.

Session MoA ?  Location Outline ? 
Semester 2 2024
Online Camperdown/Darlington, Sydney
Outline unavailable
There are no availabilities for previous years.

Modes of attendance (MoA)

This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.