Course coordinator
Dr Harendra Parekh
Course overview
- Study period
- Semester 2, 2024 (22/07/2024 - 18/11/2024)
- Study level
- Postgraduate Coursework
- Location
- External
- Attendance mode
- Online
- Units
- 2
- Administrative campus
- Dutton Park
- Coordinating unit
- Pharmacy School
Students taking this course will gain insight into the ethics and business-related aspects of product development in the pharmaceutical industry (MTP Sector). Aspects important in the product development life cycle that will be addressed include: history, role and purpose of ethics including the cultural safety in, and social impact of, research in society; legal responsibilities in research and the need for intellectual property protection; various commercialisation pathways that can bring a product to market; the business of product development touching on principles of project and financial management. Students will meet career professionals in these roles in the pharmaceutical industry and learn about the real-life practical application of theory learned.
Welcome to the course profile for PHIP7162, a course that forms part of the Masters of Pharmaceutical Industry Practice (MPIP) Program. Please email or see the course coordinator during/after lectures or tutorials for any clarification related to the learning objectives and assessment. The lecturers and course coordinator look forward to your active participation in PHIP7162.
Course requirements
Restrictions
MPharmIndPrac students only
Course contact
Course staff
Lecturer
Dr Harendra Parekh
Dr Preeti Pandey
Guest lecturer
Dr David Loch
Dr Kate Baumann
Dr Doug Horton
Dr Anthony Raphael
Emeritus Professor Ross Pinkerton
Dr Allison Sutherland
Ms April Josephsen
Ms Jennifer Larsen
Dr Katie Brooker
Timetable
The timetable for this course is available on the UQ Public Timetable.
Additional timetable information
All timetable information will be detailed in the Blackboard site for this course.
Aims and outcomes
Students will develop an understanding of the importance of intellectual property (IP), its role in the patent process and commercialisation in the pharmaceutical industry. Students will be introduced to the essential role that ethics plays in the course of product development in Australia, addressing the requirements as set out in the National Statement. They will learn the key principles of project and financial management.
Learning outcomes
After successfully completing this course you should be able to:
LO1.
Recognise the roles and diverse perspectives of human research ethics committees
LO2.
Describe the purpose of the human research ethics committee and the National Statement
LO3.
Apply different intellectual property (IP) protection strategies, evaluate their impact on a commercial model and know how patent law applies to an invention
LO4.
Evaluate the various commercialisation pathways of a novel product/invention and demonstrate the pros and cons of each
LO5.
Describe and apply the principles of project management, identifying possible risks that may occur and reasons for project success
LO6.
Identify common stakeholder roles and responsibilities in project management
LO7.
Identify the different categories of expenses in product development
Assessment
Assessment summary
| Category | Assessment task | Weight | Due date |
|---|---|---|---|
| Quiz |
Intellectual Property and Patent Law
|
20% |
16/08/2024 3:00 pm
Complete the quiz within the 24 hours prior to this deadline. |
| Presentation |
Commercialisation Pitch
|
40% |
9/09/2024 3:00 pm |
| Paper/ Report/ Annotation | Human Research Ethics Application | 20% |
30/09/2024 3:00 pm |
| Project | Project Management plan - Gantt chart | 20% |
21/10/2024 3:00 pm |
Assessment details
Intellectual Property and Patent Law
- Online
- Mode
- Written
- Category
- Quiz
- Weight
- 20%
- Due date
16/08/2024 3:00 pm
Complete the quiz within the 24 hours prior to this deadline.
- Other conditions
- Time limited.
- Learning outcomes
- L03
Task description
This assessment is a 'general knowledge' quiz in the form of multiple choice questions, and short answer questions related to Intellectual Property (IP) and Patent Law content covered in Module 1 in class activities (+ UQ Extend 'Module 1').
- This is an individual assessment that you are required to undertake without any form of communication with other students.
- This quiz is open book, so you may refer to any resource while completing it.
- This is an online quiz undertaken on your own device and in the venue of your choice.
- The quiz will comprise 15 questions selected randomly from a pool of questions, meaning each student will have different questions from their peers.
- In the case of MCQs there is only one correct answer from five options listed.
- You will have 50 minutes to complete the quiz.
- ONE attempt is permitted.
- 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
Complete the individual quiz on the 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.
Commercialisation Pitch
- Team or group-based
- Mode
- Oral, Product/ Artefact/ Multimedia
- Category
- Presentation
- Weight
- 40%
- Due date
9/09/2024 3:00 pm
- Learning outcomes
- L03, L04
Task description
- Students will work in groups (4 max.) to evaluate different commercialisation pathways by addressing the pros and cons of each, based on Module 2 in-class activities (+ UQ Extend 'Module 2').
- You will then need to agree (as a group) on which pathway would succeed in a given case and explain the reasoning via a recorded ‘group pitch’ to a virtual investor.
- Detailed instructions on preparing your group pitch recording will be provided in Week 1, during the course introduction lecture.
- You will also be required to submit a completed Group Charter, at the same time.
- 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
Submit your recorded ‘group pitch’ (all members to participate) via the submission point on Blackboard.
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.
You can request an extension on behalf of your group for a group assessment item, provided that at least 50% of your group members also agree to the request for an extension. Download and complete this form, and attach this form to your extension request:
Extension of Group Assessment - Group Member Acknowledgement (PDF, 144.9 KB)
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.
Human Research Ethics Application
- Mode
- Written
- Category
- Paper/ Report/ Annotation
- Weight
- 20%
- Due date
30/09/2024 3:00 pm
- Learning outcomes
- L01, L02
Task description
In this individual assessment, based on Module 3 in-class activities (+ UQ Extend, 'Module 3'), you will be provided a full clinical trial protocol to read and analyse. You will be required to ascertain relevant information necessary to complete question categories outlined in the provided Human Research Ethics Application (HREA) template. Further detailed requirements are available on the Blackboard site.
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
Submit responses to the HREA-related questions in the template provided, via the 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.
Project Management plan - Gantt chart
- Mode
- Written
- Category
- Project
- Weight
- 20%
- Due date
21/10/2024 3:00 pm
- Learning outcomes
- L05, L06, L07
Task description
In this individual assessment, based on Module 4 in-class activities (+ UQ Extend, 'Module 4'), students will be asked to draft a project plan. This will involve preparing a Gantt chart of a small, discrete project showing the project timeline addressing the principles of project management, including scope, any risks, and how they can be mitigated. A template is provided, see the Blackboard site.
Submission guidelines
Submit your completed Gantt chart template through the 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.
Additional learning resources information
Zoom: Access to Zoom via your UQ student account will be required for certain synchronous online classes each week (lectures & tutorials).
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 |
|---|---|---|
Not scheduled |
Not Timetabled |
UQ Extend Module 1 - IP, Patent Law Review and make notes on UQ Extend Module 1 content, PRIOR to the in-class activities covered in Week 2 & 3. Learning outcomes: L03 |
Not scheduled |
Not Timetabled |
UQ Extend Module 2 - Commercialisation Review and make notes on UQ Extend Module 2 content, PRIOR to the in-class activities covered in Week 4 & 5. Learning outcomes: L04 |
Not scheduled |
Not Timetabled |
UQ Extend Module 3 – Human Research Ethics Review and make notes on UQ Extend Module 3 content, PRIOR to the in-class activities covered in Weeks 6 to 9. Learning outcomes: L01, L02 |
Not scheduled |
Not Timetabled |
UQ Extend Module 4 - Project Management and Financial Management Review and make notes on UQ Extend Module 4 content, PRIOR to the in-class activities covered in Weeks 10 to 12. Learning outcomes: L05, L06, L07 |
Multiple weeks From Week 2 To Week 5 |
Case-based learning |
IP, Patent Law & Commercialisation Learn the importance of Patent Law and the different commercialisation pathways that can be employed in product development as well as understand the concept of Intellectual Property. Learning outcomes: L03, L04 |
Multiple weeks From Week 6 To Week 9 |
Tutorial |
Ethics in Human Research and Product Development Ethics is a critical, integral aspect of human research. Learn the importance and role of ethics in product development. Learning outcomes: L01, L02 |
Multiple weeks From Week 10 To Week 12 |
Tutorial |
Project Management and Financial Management Learn the key aspects and considerations of Project & Financial Management. Learn how to make a basic Gantt chart for a project, in a tutorial setting. Learning outcomes: 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.