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During 2021 we will continue to support students who need to study remotely due to the ongoing impacts of COVID-19 and travel restrictions. Make sure you check the location code when selecting a unit outline or choosing your units of study in Sydney Student. Find out more about what these codes mean. Both remote and on-campus locations have the same learning activities and assessments, however teaching staff may vary. More information about face-to-face teaching and assessment arrangements for each unit will be provided on Canvas.

Unit of study_

BMET4990: Biomedical Product Development

Product development in the biomedical area presents unique challenges that need to be addressed to efficiently satisfy strict regulatory requirements and to successfully advance products to approval for marketing. Biomedical engineers need a broad understanding of these challenges as the main components of product development are complex and interdependent. Development of good manufacturing and quality control processes, preclinical and clinical validation of product safety and efficacy, and regulatory filings, are each progressive and interdependent processes. This UoS will provide a broad understanding of regulatory requirements for biomedical product development, with particular emphasis on the dependence of each component on the development of processes and control systems that conform to Good Manufacturing Practice. This UoS assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development.

Details

Academic unit Biomedical Engineering
Unit code BMET4990
Unit name Biomedical Product Development
Session, year
? 
Semester 1, 2020
Attendance mode Normal day
Location Camperdown/Darlington, Sydney
Credit points 6

Enrolment rules

Prohibitions
? 
AMME4990
Prerequisites
? 
MECH2901 OR BMET2901
Corequisites
? 
None
Assumed knowledge
? 

1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level.

Available to study abroad and exchange students

Yes

Teaching staff and contact details

Coordinator Colin R Dunstan, colin.dunstan@sydney.edu.au
Type Description Weight Due Length
Presentation Presentation and discussion
10% Multiple weeks n/a
Outcomes assessed: LO1 LO2 LO3 LO4 LO5
In-semester test Exam 1
Short answer online open book exam
20% Week 06 60 minutes
Outcomes assessed: LO2 LO5 LO4 LO3
Presentation Project
25% Week 08 n/a
Outcomes assessed: LO1 LO5 LO4 LO3 LO2
Assignment Essay
25% Week 11 2000 words
Outcomes assessed: LO2 LO4 LO5
In-semester test Exam 2
Short answer online open book exam
20% Week 12 60 minutes
Outcomes assessed: LO2 LO5 LO4 LO3
  • Exams: Open book exam on course material. 
  • Assignment: Students are required to submit an assignment on a product development issue. 
  • Presentation: Group presentation on preclinical and phase I clinical trial development for a drug or device.
  • Presentation and discussion: Individual presentation and discusssion of a published paper describing a biomedical discovery or technical advance.

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.

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.

Special consideration

If you experience short-term circumstances beyond your control, such as illness, injury or misadventure or if you have essential commitments which impact your preparation or performance in an assessment, you may be eligible for special consideration or special arrangements.

Academic integrity

The Current Student website provides information on academic honesty, academic dishonesty, 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 dishonesty or plagiarism seriously.

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

WK Topic Learning activity Learning outcomes
Week 01 Product development and the regulatory environment Online class (4 hr) LO2 LO3
Week 02 Initial proof of principle studies Online class (4 hr) LO1 LO2 LO3 LO5
Week 03 Determining how medical products are distributed, degraded and cleared Online class (4 hr) LO1 LO2 LO3 LO4 LO5
Week 04 Determining medical product safety Online class (4 hr) LO1 LO2 LO3 LO4 LO5
Week 05 Good manufacturing practice Online class (4 hr) LO1 LO2 LO3 LO5
Week 06 Good manufacturing practice Online class (4 hr) LO1 LO2 LO3 LO5
Week 07 Clinical Phase 1: safety in humans Online class (4 hr) LO1 LO2 LO3 LO4
Week 08 Clinical phase 2: safety, biological activity and dose ranging Online class (4 hr) LO1 LO2 LO3 LO4
Week 09 Clinical phase 3: safety and clinical benefit Online class (4 hr) LO2 LO3 LO4
Week 10 Clinical phase 4: post-approval and making changes Online class (4 hr) LO2 LO4
Week 11 Challenges in the development of gene therapy products Online class (4 hr) LO2 LO4
Week 12 Challenges in the development of stem cell based medical products Online class (4 hr) LO2 LO3 LO4 LO5
Week 13 Testing of materials for use in devices Online class (4 hr) LO2 LO3 LO5

Attendance and class requirements

It is expected that students will attend and particpate in the tutorials.  Lecture will be recorded but students are encouraged to attend the lectures.  There will be a group presentation project.  There will be some time provided in the tutorial sessions to work on this project but some time commitment outside the tutorial times is expected.

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. demonstrate expertise in working in a team environment to develop a medical product concept and a plan for its implementation in conformity with regulatory guidelines
  • LO2. demonstrate a broad understanding of biomedical product development within the regulatory framework
  • LO3. present a complex plan for development of a drug or medical device to initial testing in human subjects
  • LO4. understand the purpose and conduct of preclinical and clinical testing
  • LO5. develop manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing 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
The tutorial sessions will be developed to encourage more preparation and contribution by the students

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.