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Unit outline_

PHAR7826: Advanced Therapies: Development and Regulation

Semester 2, 2024 [Online] - Camperdown/Darlington, Sydney

This unit will give students the skills to understand how advanced therapy products, such as cell and gene therapies, 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 regulatory requirements for registration of these types of products in Australia and globally.

Unit details and rules

Academic unit Pharmacy
Credit points 6
Prerequisites
? 
None
Corequisites
? 
None
Prohibitions
? 
PCOL5102
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Orin Chisholm, orin.chisholm@sydney.edu.au
Tutor(s) Philip Kwok, philip.kwok@sydney.edu.au
The census date for this unit availability is 2 September 2024
Type Description Weight Due Length
Assignment Reflective assignment
Reflection
30% STUVAC
Due date: 10 Nov 2024 at 23:59
1500 words
Outcomes assessed: LO1 LO2 LO3 LO4
Assignment group assignment Group project
Report
30% Week 06
Due date: 08 Sep 2024 at 23:59
3000 words
Outcomes assessed: LO1 LO2 LO3 LO4
Assignment Assignment
Assignment
40% Week 13
Due date: 03 Nov 2024 at 23:59
2000 words
Outcomes assessed: LO1 LO3 LO4
group assignment = group assignment ?

Assessment summary

  • Group Project: Working in groups, students will develop a report on a product development from R&D to registration. This project will also include the development of a group charter, and a peer review component. 
  • Assignment: Students will complete an assignment on a TGA application. 
  • 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.

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 Online class (10 hr) LO1 LO2 LO3 LO4
Week 02 Module 2: Early-stage and non-clinical development Online class (10 hr) LO1 LO2 LO3 LO4
Week 03 Module 2: Early-stage and non-clinical development Online class (10 hr) LO1 LO2 LO3 LO4
Week 04 Module 2: Early-stage and non-clinical development Online class (10 hr) LO1 LO2 LO3 LO4
Week 05 Module 3: Manufacturing considerations Online class (10 hr) LO1 LO2 LO3 LO4
Week 06 Module 3: Manufacturing considerations Online class (10 hr) LO1 LO2 LO3 LO4
Week 07 Module 4: Clinical development Online class (10 hr) LO1 LO2 LO3 LO4
Week 08 Module 4: Clinical development Online class (10 hr) LO1 LO2 LO3 LO4
Week 09 Module 5: Regulatory requirements - AU Online class (10 hr) LO1 LO2 LO3 LO4
Week 10 Module 5: Regulatory requirements - AU Online class (10 hr) LO1 LO2 LO3 LO4
Week 11 Module 6: Regulatory requirements - global Online class (10 hr) LO1 LO2 LO3 LO4
Week 12 Module 6: Regulatory requirements - global Online class (10 hr) LO1 LO2 LO3 LO4
Week 13 Module 7: HTA considerations Online class (10 hr) LO1 LO2 LO3 LO4
Week 14 (STUVAC) Module 8: Future directions 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 an advanced therapy product
  • LO2. Evaluate and construct data package requirements for the registration of an advanced therapy product in Australia
  • LO3. Perform activities associated with the role of the regulatory affairs specialist
  • LO4. Integrate knowledge, skills and experience of cell and gene therapy 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
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9

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.