Outline

Overview

This unit of study will provide students with the knowledge and skills to identify and evaluate complex technical problems and develop an implementation plan to address a problem. The unit will involve case studies from both pharmaceutical and medical device sectors, industry experts and application of international standards. Students will be given a problem from real life case studies and work through the steps to develop an implementation plan. In addition to submitting written reports, students will present their final implementation plan through recorded presentations.

Unit details and rules

Unit code	PCOL5103
Academic unit	Pharmacy
Credit points	6
Prohibitions ?	None
Prerequisites ?	None
Corequisites ?	PCOL5101 or PCOL5102
Assumed knowledge ?	None
Available to study abroad and exchange students	No

Teaching staff

Coordinator	Hui Ong, ong.hui@sydney.edu.au
Tutor(s)	Hui Ong, ong.hui@sydney.edu.au

Type	Description	Weight	Due	Length
Online task	510(k) CA (Peer Review) Discussion Board	5%	Formal exam period	At least 3 questions on a peer's work
Outcomes assessed:
Online task	Ethics Protocol 1 (Peer Review) Discussion Board	5%	Mid-semester break	At least 3 questions on a peer's work
Outcomes assessed:
Assignment	Record of Invention Written task	15%	Week 02	1000 words
Outcomes assessed:
Assignment	Ethics Protocol 1 See Canvas for details	10%	Week 04	800 words
Outcomes assessed:
Assignment	Presentation Recorded presentation	15%	Week 06	5 minutes
Outcomes assessed:
Online task	Presentation (Peer Review) Discussion Board	5%	Week 07	Comment on 2 peer's presentations
Outcomes assessed:
Assignment	Case Study Case study	15%	Week 09	Part A: 500 words, Part B: 750 words
Outcomes assessed:
Assignment	Ethics Protocol 2 See Canvas for details	10%	Week 11	800 words
Outcomes assessed:
Online task	Ethics Protocol 2 (Peer Review) Discussion Board	5%	Week 12	At least 3 questions on a peer's work
Outcomes assessed:
Assignment	510(k) CA summary Written task	15%	Week 13	1000 words
Outcomes assessed:

Assessment summary

Record of invention: Students will draft a record of invention that will form the basis for a provisional patent application based on a given scenario using a preliminary data package and the template provided.
Ethics protocols: Based on the given scenario, students will design a phase 1 clinical trial protocol for the product using the template provided.
Ethics protocol 1 and ethics protocol 2 (peer reviews): For both ethics protocol tasks, students will be assigned a partner to review their submission. Students will participate in the Discussion Board by posting at least 3 questions with regard to the assigned partner’s submission. Students will also answer/comment on the questions to clarify/defend their own submission.
Presentation: Students will record and upload a 5 minute PowerPoint presentation to the Discussion Board which outlines several key strategies that could be used to defend against claims that may be used against a company.
Presentation (peer review): Students are required to watch and comment on at least two different peers' presentations and ask at least 2 questions relating to each of their presentations in the Discussion Board. Students are also required to answer/comment on the questions directed at their own presentation.
Case study: Part A: 500 words, Part B: 750 words. Based on a given scenario, students will respond to the questions as per the detailed assessment description and information provided.
510(k) CA summary: Students will draft a 510(k)-submission document using a data package and the provided template.
510(k) CA (peer review): Students will critically evaluate their partner’s regulatory submission. Students will need to participate in the online discussion board by posting at least 3 questions with regards to their partner’s submission. Students will also answer/comment to the questions to defend changes to the device.

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.

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.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

Please note, for this unit of study (PCOL5103) the late submission penalty will be 5% of the maximum awardable mark for each calendar day after the due date for 5 calendar days only. This is to ensure that timely feedback is provided to students. If the assessment is submitted more than 5 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.

Learning support

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.

Weekly schedule

WK	Topic	Learning activity
Week 01	Module 1: pathway to registration - pharmaceutical intellectual property	Online class (10 hr)
Week 02	Module 1: pathway to registration - pharmaceutical intellectual property	Online class (10 hr)
Week 03	Module 1: pathway to registration - pharmaceutical intellectual property	Online class (10 hr)
Week 04	Module 1: pathway to registration - pharmaceutical intellectual property	Online class (10 hr)
Week 05	Module 1: pathway to registration - pharmaceutical intellectual property	Online class (10 hr)
Week 06	Module 1: pathway to registration - pharmaceutical intellectual property	Online class (10 hr)
Week 07	Module 2: medical device development - changes to existing device	Online class (10 hr)
Week 08	Module 2: medical device development - changes to existing device	Online class (10 hr)
Week 09	Module 2: medical device development - changes to existing device	Online class (10 hr)
Week 10	Module 2: medical device development - changes to existing device	Online class (10 hr)
Week 11	Module 2: medical device development - changes to existing device	Online class (10 hr)
Week 12	Module 2: medical device development - changes to existing device	Online class (10 hr)
Week 13	Module 2: medical device development - changes to existing device	Online class (10 hr)

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

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.

Outcomes
Graduate qualities

At the completion of this unit, you should be able to:

LO1. Understand the importance of intellectual property protection in the commercialisation process of medical technologies and the different regulations that governs its protections
LO2. Summarise the processes in the application of a new invention and patent
LO3. Apply the principals of good clinical practice and good record keeping during the early phases of medical technology development
LO4. Design first in human clinical trials for therapeutics and medical devices
LO5. Evaluate and defend the scientific designs and claims of a new medical technology invention
LO6. Define the processes, documentations and regulatory requirements during the different phases of medical technology development.

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
Learning outcomes

Responding to student feedback

This section outlines changes made to this unit following staff and student reviews.

No changes have been made since this unit was last offered. We value your feedback about any aspect of the unit of study and your experience as a student of Sydney Medical 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.

Additional information

Professional Education in Health - Student Hub

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.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect

Current students

PCOL5103: Therapeutics and Device Innovations (Project)

Semester 1, 2021 [Online] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect