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 studying this course will gain a comprehensive understanding of post-marketing environment by interacting from industry experts within the allied disciplines, which oversee the continued growth of the product once regulators have approved the product. These allied disciplines include medical affairs, pharmacovigilance and risk management, health technology assessment (including economic evaluations), and marketing. By hearing from industry professionals in these fields, students will acquire a significant understanding of the roles in managing the product through various stages of its growth and how these professionals work with government to bring needed medicines to the consumer. Students will extend their learning by undertaking assessment that uses real life cases.
Welcome to the course profile for PHIP7142, a part of the Masters of Pharmaceutical Industry Practice. Please email or see the course co-ordinator for any clarifications around any assessment or policy information.
Course requirements
Restrictions
MPharmIndPrac students only
Jointly taught details
This course is jointly-taught with:
- Another instance of the same course
PHIP7142 attendance mode: external
Course contact
Course staff
Lecturer
Dr Keshia De Guzman
Dr Centaine Snoswell
Ms Rose-marie Pennisi
Ms Christina Lake
Tutor
Dr Centaine Snoswell
Timetable
The timetable for this course is available on the UQ Public Timetable.
Additional timetable information
See the eLearning/Blackboard site and UQ public timetable for information
Aims and outcomes
The course aims to introduce students to the post-registration processes for pharmaceuticals with specific examples from Australia, where the gained knowledge is useful globally. These processes encompass four main areas: (a) post-marketing pharmacovigilance, (b) medical affairs, (c) marketing, and (d) health technology assessment.
Learning outcomes
After successfully completing this course you should be able to:
LO1.
Explain the main features of the Australian health care system
LO2.
Explain the functions of medical affairs and marketing in drug development
LO3.
Describe and differentiate the guidelines, documents, and safety events in pharmacovigilance
LO4.
Critically appraise the core components of health technology assessment and economic evaluations including costs, health outcomes and institutional context
Assessment
Assessment summary
| Category | Assessment task | Weight | Due date |
|---|---|---|---|
| Quiz |
Australian health care system
|
10% |
7/08/2024 2:00 pm
Complete the quiz during the 7 days prior to the due date. |
| Presentation, Poster |
Poster presentation (medical affairs, marketing and codes)
|
20% |
12/08/2024 12:00 pm |
| Quiz |
Pharmacovigilance
|
30% |
10/09/2024 12:00 pm
Complete the quiz during the 24-hours prior to the due date/time. Opens Monday (Week 8) at 12 pm (noon). |
| Essay/ Critique | Critical appraisal (Health Technology Assessment) | 40% |
8/11/2024 2:00 pm |
A hurdle is an assessment requirement that must be satisfied in order to receive a specific grade for the course. Check the assessment details for more information about hurdle requirements.
Assessment details
Australian health care system
- Online
- Mode
- Written
- Category
- Quiz
- Weight
- 10%
- Due date
7/08/2024 2:00 pm
Complete the quiz during the 7 days prior to the due date.
- Other conditions
- Time limited.
- Learning outcomes
- L01, L02, L03, L04
Task description
- This is an online quiz based on the content from Week 1: online content (UQ Extend) and the AHCS introduction lecture.
- PHIP7142 uses Inspera for the quizzes. These will be a non-invigilated digital assessments and students in this course will complete and submit this using their own device. Further details, including an introduction to Inspera functionality, practice opportunities, and where to go for support, will be provided in the Blackboard site for this course.
- The format may be a mixture of question types, for example: multiple choice, multiple answer, matching, ordering, fill in the blank/s, jumbled sentence/s, either/or (e.g. true/false), short answer.
- ONE attempt is permitted for this quiz.
- The quiz duration is 20 minutes.
- The quiz will be marked electronically, correct answers will be awarded the marks indicated beside the question, incorrect answers will be awarded zero.
- 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
Deferral or extension
You cannot defer or apply for an extension for this assessment.
Poster presentation (medical affairs, marketing and codes)
- Identity Verified
- In-person
- Mode
- Oral
- Category
- Presentation, Poster
- Weight
- 20%
- Due date
12/08/2024 12:00 pm
- Learning outcomes
- L02, L03
Task description
This assessment task is designed to improve your understanding of marketing and codes related to drug development and your ability to communicate concepts in scientific, clinical, and the legal context. Prepare a poster and give an oral presentation using the poster.
The assessment is based on the following scenario: You are a medical liaison officer at a pharmaceutical company called Bestceuticals. You’ve just completed your training in medical affairs and you become aware that your company may potentially be about to breach a legal code, similar to that of a previous competitor case. So, the Board of Directors has asked for an urgent meeting with teams from R&D, regulatory affairs, PV, compliance, and marketing and sales.
You are to present a poster presentation of no more than 4 minutes; the presentation is to provide:
- A basic overview of a historical case (product/company and nature of the complaint regarding the advertising/marketing).
- Explanation about the code/s that were breached. In addition, describe any sanction/s and fines that were put in place by regulators and how this could have been avoided. What other legal aspects (e.g. regulations) could be implicated in your allocated case? Are there other historical cases that can help inform your company?
- If the initial meeting with the board of directors concludes and it's found that there is likely to be a breach of code, then name THREE key stakeholders that you’d like to have onboard for future meetings. How might this task group help your company avoid damaging commercial impact?
You will also be asked a series of questions after your presentation (no more than 1 minute). Questions will be mostly general and asking for more detail.
Poster style:
- Your poster should be presented as a SINGLE PowerPoint slide for projection as an e-poster. The slide must contain no movies, transitions or animations, i.e. the slide is static.
- The poster must contain a clear title.
- The bottom left-hand corner of your poster must contain your name.
- Where possible the use of tables, diagrams and/or images to explain concepts is encouraged. Minimising the quantity of text and use of bullet points also strongly encouraged.
- Consider the viewer's ability to read the poster when selecting font size, style and images.
- Bring the PowerPoint compatible slide on a USB drive for submission at the start of the presentation session.
This oral assessment 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 Blackboard for more details.
Submission guidelines
Deferral or extension
You cannot defer or apply for an extension for this assessment.
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.
Pharmacovigilance
- Hurdle
- Online
- Mode
- Written
- Category
- Quiz
- Weight
- 30%
- Due date
10/09/2024 12:00 pm
Complete the quiz during the 24-hours prior to the due date/time. Opens Monday (Week 8) at 12 pm (noon).
- Other conditions
- Time limited.
- Learning outcomes
- L03, L04
Task description
- This is an online quiz based on the content from Weeks 4 to 7: online content (UQ Extend), lectures, and PBL sessions on PV.
- This is a non-invigilated digital assessment and students in this course will complete and submit using their own device. Further details, including an introduction to Inspera functionality, practice opportunities, and where to go for support, will be provided in the Blackboard site for this course.
- The format may be a mixture of question types, for example: multiple choice, multiple answer, matching, ordering, fill in the blank/s, jumbled sentence/s, either/or (e.g. true/false), short answer.
- ONE attempt is permitted for this quiz.
- Complete the quiz during the open period of 24-hours.
- Once started, the quiz duration is 60 minutes with an additional 10 minutes of reading time.
- The quiz will be marked electronically, correct answers will be awarded the marks indicated beside the question, incorrect answers will be awarded zero.
- 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.
Hurdle requirements
Must pass this assessment (achieve 50% or greater) to pass the course.Submission guidelines
Submission: The quiz will be completed electronically in Inspera.
Resubmission: Students who have submitted this assessment on time but have not achieved a pass (i.e. obtain less than 50% of available marks) will be offered one opportunity to resubmit; the maximum grade that can be achieved for the resubmission will be a pass (50% of available marks). No extension is available on the due date for a resubmission
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.
Critical appraisal (Health Technology Assessment)
- Mode
- Written
- Category
- Essay/ Critique
- Weight
- 40%
- Due date
8/11/2024 2:00 pm
- Learning outcomes
- L04
Task description
More detail will be specified in the Blackboard website from Week 10.
This will be an assignment focusing on economic evaluations and assessed in two parts;
Task 1. Completing the CHEERS checklist and answering the following questions (5%):
- State the article details (first author, year, journal)?
- What economic evaluation (EE) method was used?
- What was the CHEERS score for your article (sum of total)?
Task 2. Reviewing current literature that conducted an econ eval (EE) within the context of health technology assessment - HTA by answering the following questions (35%):
- What perspective did the authors take for the analysis?
- What were the main findings of the analysis?
- 3A. Do you believe that the costing was appropriate? 3B. Were there any items that were omitted or included that would have changed the outcome? Please explain why.
- Was the outcome measure selected appropriate for the intervention? Explain your answer including potential alternative outcome measures.
- If you were advising budget holders in Australia, based on the evidence from the analysis is this intervention worth investing in? Please explain why.
- What would need to be considered to make the results of this analysis applicable to the Australian setting?
Referencing style needs to be consistent (i.e. can use any style but must remain consistent throughout the assessment).
Steps for submission:
1. Ensure the first page has your name and ID clearly stated.
2. Save as Microsoft Word document (not PDF, JPEG or any other format)
3. Upload to the link in the assessment folder on Blackboard by the due date.
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
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
Library resources are available on the UQ Library website.
Additional learning resources information
Relevant resources will be noted in lectures and tutorials and on the course Blackboard site.
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 |
|---|---|---|
Week 1 (22 Jul - 28 Jul) |
Lecture |
Australian Healthcare System (AHCS) Lectures delivered in-persons for those in Australia and via ZOOM for those enrolled externally/overseas. Overview of AHCS, including acute vs chronic care, medication funding through the PBS, the registration of medicines and the TGA, and health inequality. Readings/Ref: online learning via UQ Extend. Learning outcomes: L01, L02, L03, L04 |
Multiple weeks From Week 2 To Week 12 |
Problem-based learning |
PBL activities Problem-based learning sessions commence in week 2 and attendance is strongly recommended. These sessions are designed to teach industry skills using cases and application of guidelines and codes. Students will also be introduced to specific guidelines and codes (Med Affairs and PV) and economic evaluation (EEs) as part of health technology assessment (HTA). Readings/Ref: online learning via UQ Extend. Learning outcomes: L02, L03, L04 |
Multiple weeks From Week 2 To Week 3 |
Lecture |
Medical Affairs & Marketing History of the pharmaceutical code, advisory boards, and Medicines Australia (MedAus). Readings/Ref: online learning via UQ Extend. Learning outcomes: L02, L04 |
Multiple weeks From Week 4 To Week 7 |
Lecture |
Pharmacovigilance History, major agencies, adverse events and reporting, risk management, and signals. Readings/Ref: online learning via UQ Extend. Learning outcomes: L03, L04 |
Multiple weeks From Week 9 To Week 12 |
Lecture |
Health Technology Assessment Economic evaluations (EEs), trials and evidence, EE & costs, EE outcomes, CHEERS, and challenges in the context of quality-adjusted life-year (QLAY) and quality of life (QOL). Readings/Ref: online learning via UQ Extend. Learning outcomes: L03, L04 |
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.