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Unit of study_

PCOL5104: Pharm and Medical Device Development

Semester 2, 2022 [Online] - Camperdown/Darlington, Sydney

This capstone unit develops the critical thinking needed to transform a new therapeutic drug or a device into a commercially viable product. Students will critically appraise scientific and clinical data and information in order to prepare sections of the final scientific dossier that would be suitable for submission to the TGA, EMA or FDA. Students will determine the submission strategy and solve clinical/scientific issues related to core aspects of the process (i.e. chemistry, manufacturing, quality, stability, safety, clinical trial or other suitable component of the process).

Unit details and rules

Unit code PCOL5104
Academic unit Pharmacy
Credit points 6
Prohibitions
? 
None
Prerequisites
? 
None
Corequisites
? 
CEPI5100 and 18 credit points of stream specific units of study from any of (PCOL5101, PCOL5102, PCOL5103, PCOL5105, PHAR7815)
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Philip Kwok, philip.kwok@sydney.edu.au
Tutor(s) Orin Chisholm, orin.chisholm@sydney.edu.au
Type Description Weight Due Length
Assignment Common Technical Document
Please see Canvas for details
40% Week 05
Due date: 04 Sep 2022 at 23:59
2500 words
Outcomes assessed: LO1 LO3 LO4 LO2
Assignment Medical Device Essential Principles
Please see Canvas for details
40% Week 09
Due date: 09 Oct 2022 at 23:59
2500 words
Outcomes assessed: LO1 LO3 LO4 LO2
Presentation Presentation
Pre-recorded presentation
18% Week 12
Due date: 30 Oct 2022 at 23:59
7 minutes
Outcomes assessed: LO3 LO5
Online task Presentation - Peer Review
Discussion posts
2% Week 13 1x peer review question 1x peer response
Outcomes assessed: LO3 LO5

Assessment summary

Presentation: Students will prepare a 7-minute pre-recorded presentation, task prompts will be provided. There is an additional peer review task tied to this assessment. 

Common Technical Document (CTD): Students will prepare a CTD of 2500 words on a selected product. A list of products will be provided. 

Medical Device Essential Principles: Students will prepare essential principles documentation of 2500 words for a medical device. A scenario, template and prompts will be provided. 

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

At HD level, a student demonstrates an aptitude for the subject and a well-developed understanding of the unit material. A ‘High Distinction’ reflects exceptional achievement and is awarded to students who demonstrate the ability to apply their subject knowledge and understanding to produce original solutions for novel or highly complex problems and/or comprehensive critical discussions of theoretical concepts. 

Distinction

75 - 84

At DI level, a student demonstrates an aptitude for the subject and a well-developed understanding of the units material. A ‘Distinction’ reflects excellent achievement and is awarded to a student who demonstrates an ability to apply their subject knowledge and understanding of the subject to produce good solutions for challenging problems and/or a reasonably well-developed critical analysis of theoretical concepts. 

Credit

65 - 74

At CR level, a student demonstrates a good command and knowledge of the unit material. A ‘Credit’ reflects solid achievement and is awarded to a student who has a broad general understanding of the units material and can solve routine problems and/ or identify and superficially discuss theoretical concepts. 

Pass

50 - 64

At PS level, a student demonstrates proficiency in the material. A ‘Pass’ reflects satisfactory adequately referencing the original source of the work. 

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.

WK Topic Learning activity Learning outcomes
Multiple weeks Module 3: Tomorrow's Therapies and Devices Seminar (10 hr) LO3 LO5
Week 01 Module 1: Regulatory Submission for Pharmaceutical Products Seminar (10 hr) LO1 LO2 LO3 LO4
Week 02 Module 1: Regulatory Submission for Pharmaceutical Products Seminar (10 hr) LO1 LO2 LO3 LO4
Week 03 Module 1: Regulatory Submission for Pharmaceutical Products Seminar (10 hr) LO1 LO2 LO3 LO4
Week 04 Module 1: Regulatory Submission for Pharmaceutical Products Seminar (10 hr) LO1 LO2 LO3 LO4
Week 05 Module 1: Regulatory Submission for Pharmaceutical Products Seminar (10 hr) LO1 LO2 LO3 LO4
Week 06 Module 2: Regulatory Submission for Medical Devices Seminar (10 hr) LO1 LO2 LO3 LO4
Week 07 Module 2: Regulatory Submission for Medical Devices Seminar (10 hr) LO1 LO2 LO3 LO4
Week 08 Module 2: Regulatory Submission for Medical Devices Seminar (10 hr) LO1 LO2 LO3 LO4
Week 09 Module 2: Regulatory Submission for Medical Devices Seminar (10 hr) LO1 LO2 LO3 LO4
Week 10 Module 2: Regulatory Submission for Medical Devices Seminar (10 hr) LO1 LO2 LO3 LO4
Week 11 Module 3: Tomorrow's Therapies and Devices Seminar (10 hr) LO3 LO5
Week 12 Module 3: Tomorrow's Therapies and Devices Seminar (10 hr) LO3 LO5

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. Identify and outline the requirements for compiling the Common Technical Document (CTD) for pharmaceuticals and Market Authorisation approval document for a medical device
  • LO2. Explain the purpose, regulatory requirements and regional differences for the Common Technical Document and Market Authorisation submissions according to the latest guidelines
  • LO3. Critically appraise available data and literature for relevance to the regulatory submission
  • LO4. Systematically compile pertinent data into a final dossier for submission to the regulatory body
  • LO5. Understand and compare the regulatory processes for traditional and unconventional medicinal products and medical devices

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.

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 ask you to complete the Mid-Semester Evaluation Survey and the unit of study Evaluation Survey at the end of the semester. You can also rate any component of the unit using our star rating system found at the bottom of many pages as you progress through the unit. Your ratings and comments are anonymous and specifying what you liked and didn’t like about any of the learning materials, assessment items, discussion forums, feedback etc will help us to target our improvement efforts. 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.