Course overview
- Study period
- Semester 1, 2025 (24/02/2025 - 21/06/2025)
- Study level
- Postgraduate Coursework
- Location
- Dutton Park
- Attendance mode
- In Person
- Units
- 2
- Administrative campus
- Dutton Park
- Coordinating unit
- Pharmacy and Pharmaceutical Sciences School
In this course students will learn about process of medical device development, manufacturing of drugs under strict GMP conditions, as well as regulatory and governance aspects of the two. Medical device development is an increasing area of clinical research and development in Australia, and globally. Students will learn in detail about methods of device manufacturing, and cutting-edge advanced techniques for developing and fabrication of medical devices, including 3D printing. They will learn about the guidelines that govern good practices in the R&D of medical devices. They will learn about the guidelines that govern good practice in manufacturing of devices and drugs. This will extend into description of upscaling processes for small batches required for pre-clinical proof-of-concept studies through to large batches required for clinical trials. They will learn about the various types of packaging for different medical devices and medicines, and this will be aligned to regulations set by the Therapeutic Goods Administration (TGA) of Australia. They will learn about the various labelling requirements on the global stage and innovative labelling and packaging practices. Exposure to the regulation of therapeutic goods in Australia, how it compares to those overseas and why we have regulators along with the principles of research governance is a feature of this course.
Course requirements
Restrictions
MPharmIndPrac students only
Course contact
Course staff
Lecturer
Dr Harendra Parekh
Timetable
The timetable for this course is available on the UQ Public Timetable.
Additional timetable information
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Aims and outcomes
This course aims to develop your knowledge in medical device development, and Good Manufacturing Practice (GMP) as it relates to medical device and drug manufacturing, as well as the regulatory and governance aspects of the two (medical device development and drug manufacturing); this will be approached from a Therapeutic Goods Administration (TGA) and global perspective.
ﾠ
Learning outcomes
After successfully completing this course you should be able to:
LO1.
Describe the development processes of medical devices
LO2.
Identify the regulatory processes for approval of medical devices
LO3.
Evaluate good manufacturing practice and how it relates to medical device manufacture
LO4.
Compare and contrast GMP between medical devices and drug manufacturing
LO5.
Describe the development and role of pharmaceutical packaging and labeling
LO6.
Explain the importance and application of quality control systems
LO7.
Work effectively in a team environment
Assessment
Assessment summary
| Category | Assessment task | Weight | Due date |
|---|---|---|---|
| Poster |
Digital poster & pitch of drug/medical device
|
40% |
14/04/2025
The presentation schedule will be available on Learn.UQ (Blackboard). |
| Tutorial/ Problem Set |
Pharmaceutical Quality System scenarios
|
30% |
6/05/2025 4:00 pm
Complete the 1-hour long assessment during the 3 hours prior to this deadline. |
| Quiz |
End of Semester Quiz
|
30% |
9/06/2025 5:00 pm
Complete the quiz between 9am & 5pm (AEST) i.e. 8-hr completion window. |
Assessment details
Digital poster & pitch of drug/medical device
- Identity Verified
- Team or group-based
- In-person
- Mode
- Oral, Product/ Artefact/ Multimedia
- Category
- Poster
- Weight
- 40%
- Due date
14/04/2025
The presentation schedule will be available on Learn.UQ (Blackboard).
- Other conditions
- Student specific, Time limited.
- Learning outcomes
- L01, L03, L07
Task description
Digital Poster (15%):
- As a syndicate of 3-4 students, prepare a digital poster that describes key features of a drug/medical device technology detailed in a journal article assigned to the syndicate.
- All members of the syndicate receive the same mark for the poster.
Oral presentation (25%):
- Each syndicate member will present one of the four sections of the digital poster (i.e. "Introduction" or "Materials & Methods" or "Results and Discussion" or "Conclusions & Future Prospects") to a virtual investor panel. The pitch will be 10 minutes, comprised of 2 mins per section (four sections), plus 2 mins Q&A.
- Each member of the syndicate receives an individual mark for their presentation.
- The Oral Presentation will be recorded and retained as per university policy. The recording will be stored in a secure manner and will only be accessed if required for the purposes of moderation of marking; provision of feedback to the student; and/or re-marking following a successful re-mark application.
See the Learn.UQ (Blackboard) site for more details and the marking criteria.
This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) and Machine Translation (MT) technologies, successful completion of the assessment will require students to critically engage in specific contexts and tasks for which AI will provide only limited support and guidance. A failure to reference AI or MT use may constitute student misconduct under the Student Code of Conduct. To pass this assessment, students will be required to demonstrate detailed comprehension of their written submission independent of AI and MT tools.
Submission guidelines
Submission instructions are provided on the Learn.UQ (Blackboard) site.
Deferral or extension
You may be able to apply for an extension.
The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.
Late submission
A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.
Pharmaceutical Quality System scenarios
- Online
- Mode
- Written
- Category
- Tutorial/ Problem Set
- Weight
- 30%
- Due date
6/05/2025 4:00 pm
Complete the 1-hour long assessment during the 3 hours prior to this deadline.
- Other conditions
- Time limited.
- Learning outcomes
- L01, L02, L03, L06
Task description
Describe the processes of troubleshooting problems/breaches in pharmaceutical quality systems (PQS) at a drug/device manufacturing facility, based on given scenarios.
- Two scenarios will be presented.
- Four questions will be answered in relation to each scenario.
- This is an open book assessment.
- The assessment is available for completion from 1 pm and closes at 4 pm.
- Once started, there is a maximum of 1 hour available to complete this assessment, i.e. 30 mins per pharmaceutical quality system (PQS) problem set/scenario. The assessment will auto-submit when one hour has elapsed.
- See the Learn.UQ (Blackboard) site for more details and the marking criteria.
- This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) and Machine Translation (MT) technologies, successful completion of the assessment will require students to critically engage in specific contexts and tasks for which AI will provide only limited support and guidance.
Submission guidelines
Responses will be submitted within the Learn.UQ (Blackboard) site.
Deferral or extension
You may be able to apply for an extension.
The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.
Late submission
A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.
End of Semester Quiz
- Online
- Mode
- Written
- Category
- Quiz
- Weight
- 30%
- Due date
9/06/2025 5:00 pm
Complete the quiz between 9am & 5pm (AEST) i.e. 8-hr completion window.
- Other conditions
- Time limited.
- Learning outcomes
- L01, L02, L03, L04, L05, L06
Task description
- This is an end of semester digital (online) quiz covering whole course content.
- The quiz comprises MCQ questions accessed via Learn.UQ (Blackboard).
- Complete the quiz anytime between 9am & 5pm i.e. 8-hr completion window.
- Quiz duration 60 minutes (max.)
- ONE attempt at the quiz is permitted.
- See the Learn.UQ (Blackboard) site for more details and the marking criteria.
- This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) and Machine Translation (MT) technologies, successful completion of the assessment will require students to critically engage in specific contexts and tasks for which AI will provide only limited support and guidance.
Submission guidelines
Responses will be submitted within the Learn.UQ (Blackboard) site.
Deferral or extension
You may be able to apply for an extension.
The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.
Late submission
A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.
Course grading
Full criteria for each grade is available in the Assessment Procedure.
| Grade | Cut off Percent | Description |
|---|---|---|
| 1 (Low Fail) | 1 - 29 |
Absence of evidence of achievement of course learning outcomes. |
| 2 (Fail) | 30 - 44 |
Minimal evidence of achievement of course learning outcomes. |
| 3 (Marginal Fail) | 45 - 49 |
Demonstrated evidence of developing achievement of course learning outcomes |
| 4 (Pass) | 50 - 64 |
Demonstrated evidence of functional achievement of course learning outcomes. |
| 5 (Credit) | 65 - 74 |
Demonstrated evidence of proficient achievement of course learning outcomes. |
| 6 (Distinction) | 75 - 84 |
Demonstrated evidence of advanced achievement of course learning outcomes. |
| 7 (High Distinction) | 85 - 100 |
Demonstrated evidence of exceptional achievement of course learning outcomes. |
Supplementary assessment
Supplementary assessment is available for this course.
Learning resources
You'll need the following resources to successfully complete the course. We've indicated below if you need a personal copy of the reading materials or your own item.
Library resources
Find the required and recommended resources for this course on the UQ Library website.
Learning activities
The learning activities for this course are outlined below. Learn more about the learning outcomes that apply to this course.
Filter activity type by
Please select
| Learning period | Activity type | Topic |
|---|---|---|
Multiple weeks From Week 1 To Week 13 |
Lecture |
Lectures
Learning outcomes: L01, L02, L03, L04, L05, L06, L07 |
Multiple weeks From Week 2 To Week 13 |
Tutorial |
Tutorials
Learning outcomes: L01, L02, L03, L04, L05, L06, L07 |
Policies and procedures
University policies and procedures apply to all aspects of student life. As a UQ student, you must comply with University-wide and program-specific requirements, including the:
- Student Code of Conduct Policy
- Student Integrity and Misconduct Policy and Procedure
- Assessment Procedure
- Examinations Procedure
- Reasonable Adjustments - Students Policy and Procedure
Learn more about UQ policies on my.UQ and the Policy and Procedure Library.