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Unit of study_

PHAR7817: Pharmaceuticals: Development and Regulation

Semester 1, 2024 [Online] - Camperdown/Darlington, Sydney

This unit of study provides a broad overview of the processes involved in translating a new pharmaceutical product from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical industry. This unit will give students the skills to understand how medicines are researched, developed and regulated. The regulatory requirements for chemistry, manufacturing and controls, pre-clinical testing including toxicity studies, and clinical testing will be discussed. Finally, the unit will examine the legal and regulatory requirements for registration of these types of products.

Unit details and rules

Unit code PHAR7817
Academic unit Pharmacy
Credit points 6
Assumed knowledge


Available to study abroad and exchange students


Teaching staff

Coordinator Orin Chisholm,
Guest lecturer(s) Slade Matthews,
Noelia Nebot,
Lecturer(s) Philip Kwok,
Tutor(s) Belinda Butcher,
Type Description Weight Due Length
Assignment Assignment
Due date: 02 Jun 2024 at 23:59
1500 words
Outcomes assessed: LO4
Online task group assignment Group Project
group project
30% Week 08
Due date: 21 Apr 2024 at 23:59
3000 words
Outcomes assessed: LO1
Assignment Assignment
40% Week 13
Due date: 26 May 2024 at 23:59
2000 words
Outcomes assessed: LO2 LO3
group assignment = group assignment ?

Assessment summary

  • Group Project: Working in groups, students will develop a report on a particular aspect of product development. This project will also include the development of a group charter, and a peer review component. 
  • Assignment: Students will complete an assignment on an aspect of product development or regulatory submission. 
  • 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

Result name

Mark range


High distinction

85 - 100



75 - 84



65 - 74



50 - 64



0 - 49

When you don’t meet the learning outcomes of the unit to a satisfactory standard.


For more information see guide to grades.

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 Current Student website  provides information on academic integrity and the resources available to all students. The University expects students and staff to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.  

We use similarity detection software to detect potential instances of plagiarism or other forms of academic integrity breach. If such matches indicate evidence of plagiarism or other forms of academic integrity breaches, your teacher is required to report your work for further investigation.

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

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 2023 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 2023. 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

WK Topic Learning activity Learning outcomes
Week 01 Module 1 – Introduction to pharmaceutical product development and lifecycle Online class (10 hr) LO1 LO2 LO3 LO4
Week 02 Module 2 – Preclinical development of pharmaceutical products Online class (10 hr) LO1 LO2 LO3 LO4
Week 03 Module 3 – Product quality, manufacturing and GMP Online class (10 hr) LO1 LO2 LO3 LO4
Week 04 Module 4 – Clinical development of pharmaceutical products Online class (10 hr) LO1 LO2 LO3 LO4
Week 05 Module 4 – Clinical development of pharmaceutical products Online class (10 hr) LO1 LO2 LO3 LO4
Week 06 Module 4 – Clinical development of pharmaceutical products Online class (10 hr) LO1 LO2 LO3 LO4
Week 07 Module 5 – Australian legal and therapeutic product regulatory system Online class (10 hr) LO1 LO2 LO3 LO4
Week 08 Module 5 – Australian legal and therapeutic product regulatory system Online class (10 hr) LO1 LO2 LO3 LO4
Week 09 Module 5 – Australian legal and therapeutic product regulatory system Online class (10 hr) LO1 LO2 LO3 LO4
Week 10 Module 5 – Australian legal and therapeutic product regulatory system Online class (10 hr) LO1 LO2 LO3 LO4
Week 11 Module 6 – Regulation of pharmaceutical products internationally Online class (10 hr) LO1 LO2 LO3 LO4
Week 12 Module 6 – Regulation of pharmaceutical products internationally Online class (10 hr) LO1 LO2 LO3 LO4
Week 13 Module 6 – Regulation of pharmaceutical products internationally Online class (10 hr) LO1 LO2 LO3 LO4

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 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.

At the completion of this unit, you should be able to:

  • LO1. Explain the major milestones involved in the lifecycle of a pharmaceutical product
  • LO2. Evaluate and construct data package requirements for the registration of a pharmaceutical product in Australia
  • LO3. Perform activities associated with the role of the regulatory affairs specialist
  • LO4. Integrate knowledge, skills and experience of pharmaceutical product development and regulation 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

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

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 ask you to complete the Unit of Study Evaluation Survey (USS) 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.


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.