Outline

Overview

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
Credit points	6
Prerequisites ?	None
Corequisites ?	None
Prohibitions ?	None
Assumed knowledge ?	None
Available to study abroad and exchange students	Yes

Teaching staff

Coordinator	Orin Chisholm, orin.chisholm@sydney.edu.au
Tutor(s)	Philip Kwok, philip.kwok@sydney.edu.au

Assessment

The census date for this unit availability is 1 September 2025

Details
Criteria

Type	Description	Weight	Due	Length	Use of AI
Written work	Reflective assignment Reflection	30%	STUVAC Due date: 09 Nov 2025 at 23:59	See canvas for details	AI allowed
Outcomes assessed:
Written work	Group charter and project outline Write a group charter and a project outline	0%	Week 03 Due date: 24 Aug 2025 at 23:59	See canvas for details.	AI allowed
Outcomes assessed:
Written work	Group project Group project with peer review task	30%	Week 08 Due date: 28 Sep 2025 at 23:59	See canvas for details	AI allowed
Outcomes assessed:
Presentation	Presentation Individual work	40%	Week 12	See canvas for details	AI allowed
Outcomes assessed:
= group assignment ?

Assessment summary

Group Project: Working in groups, students will complete a report on a particular product and specific product indication. This project will also include the development of a group charter, and a peer review component.
Assignment: Students will complete an presentation on a particular are of therapeutic product development.
Reflective Assignment: Students are expected to keep an reflective journal throughout their studies and this final reflection will require students to draw links between their studies and their workplace and self-development plans.

Detailed information for each assessment can be found on Canvas.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name	Mark range	Description
High distinction	85 - 100
Distinction	75 - 84
Credit	65 - 74
Pass	50 - 64
Fail	0 - 49	When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see sydney.edu.au/students/guide-to-grades.

For more information see guide to grades.

Use of generative artificial intelligence (AI)

You can use generative AI tools for open assessments. Restrictions on AI use apply to secure, supervised assessments used to confirm if students have met specific learning outcomes.

Refer to the assessment table above to see if AI is allowed, for assessments in this unit and check Canvas for full instructions on assessment tasks and AI use.

If you use AI, you must always acknowledge it. Misusing AI may lead to a breach of the Academic Integrity Policy.

Visit the Current Students website for more information on AI in assessments, including details on how to acknowledge its use.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

Deduction of 5% of the maximum mark for each calendar day after the due date.
After ten calendar days late, a mark of zero will be awarded.

Academic integrity

The University expects students to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.

Our website provides information on academic integrity and the resources available to all students. This includes advice on how to avoid common breaches of academic integrity. Ensure that you have completed the Academic Honesty Education Module (AHEM) which is mandatory for all commencing coursework students

Penalties for serious breaches can significantly impact your studies and your career after graduation. It is important that you speak with your unit coordinator if you need help with completing assessments.

Visit the Current Students website for more information on AI in assessments, including details on how to acknowledge its use.

Learning support

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

Support for students

The Support for Students Policy reflects the University’s commitment to supporting students in their academic journey and making the University safe for students. It is important that you read and understand this policy so that you are familiar with the range of support services available to you and understand how to engage with them.

The University uses email as its primary source of communication with students who need support under the Support for Students Policy. Make sure you check your University email regularly and respond to any communications received from the University.

Learning resources and detailed information about weekly assessment and learning activities can be accessed via Canvas. It is essential that you visit your unit of study Canvas site to ensure you are up to date with all of your tasks.

If you are having difficulties completing your studies, or are feeling unsure about your progress, we are here to help. You can access the support services offered by the University at any time:

Support and Services (including health and wellbeing services, financial support and learning support)
Course planning and administration
Meet with an Academic Adviser

Weekly schedule

WK	Topic	Learning activity
Week 01	Module 1: History of vigilance, definitions and mechanisms of adverse effects	Online class (10 hr)
Week 02	Module 2: Vigilance systems in Australia	Online class (10 hr)
Week 03	Module 2: Vigilance systems in Australia	Online class (10 hr)
Week 04	Module 2: Vigilance systems in Australia	Online class (10 hr)
Week 05	Module 3: Risk management systems	Online class (10 hr)
Week 06	Module 3: Risk management systems	Online class (10 hr)
Week 07	Module 4: Audits, inspections, and partnerships	Online class (10 hr)
Week 08	Module 4: Audits, inspections, and partnerships	Online class (10 hr)
Week 09	Module 4: Audits, inspections, and partnerships	Online class (10 hr)
Week 10	Module 4: Audits, inspections, and partnerships	Online class (10 hr)
Week 11	Module 5: International vigilance systems	Online class (10 hr)
Week 12	Module 5: International vigilance systems	Online class (10 hr)
Week 13	Module 5: International vigilance systems	Online class (10 hr)
Week 14 (STUVAC)	Module 6: Ethics, societal considerations and future directions	Online class (10 hr)

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University's graduate qualities and are assessed as part of the curriculum.

Outcomes
Graduate qualities

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

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1	Depth of disciplinary expertise Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.
GQ2	Critical thinking and problem solving Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.
GQ3	Oral and written communication Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.
GQ4	Information and digital literacy Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.
GQ5	Inventiveness Generating novel ideas and solutions.
GQ6	Cultural competence Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.
GQ7	Interdisciplinary effectiveness Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.
GQ8	Integrated professional, ethical, and personal identity An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.
GQ9	Influence Engaging others in a process, idea or vision.

Outcome map

Learning outcomes	Graduate qualities
Learning outcomes

Responding to student feedback

This section outlines changes made to this unit following staff and student reviews.

This is the first time this unit has been offered. We value your feedback about any aspect of the unit of study and your experience as a student of Sydney Pharmacy School. To help ensure our courses meet your needs and maintain a high standard, we welcome your feedback at any time and we encourage you to complete the unit of study Evaluation Survey at the end of the semester. You will also have the opportunity to give feedback to the student representatives who will inform the program Advisory Board and staff of this feedback. Please note that your participation in this unit of study permits de-identified information about your learning experience and interaction with learning resources to be used for the purpose of improving the student learning experience.

Disclaimer

The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

To help you understand common terms that we use at the University, we offer an online glossary.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Use of generative artificial intelligence (AI)

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Support for students

Weekly schedule

Weekly schedule

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Disclaimer

On this page

Useful links

PHAR7825: Therapeutic Product Vigilance

Semester 2, 2025 [Online] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Use of generative artificial intelligence (AI)

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Support for students

Weekly schedule

Weekly schedule

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Disclaimer

On this page

Useful links