PCOL5102: Semester 2 Early, 2020

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Units PCOL5102 Semester 2 Early 2020 [Online]

Unit of study_

PCOL5102: Modern Therapeutics and Medical Devices

Semester 2 Early, 2020 [Online] - Camperdown/Darlington, Sydney

Overview

This unit of study develops knowledge in current state-of-the-art therapeutic technologies. The principles of mode of action are investigated, along with methods of manufacture and registration. The unit is targeted at people already in or interested in the pharmaceutical and medical devices industries, and advisors in the regulatory sector. It covers 4 core areas of regulation in Australia: (1) biologicals and personalised medicine, (2) cell based products, (3) medical devices and (4) classical formulations. The principles that underpin these innovative therapies are covered in terms of development, targeting and manufacture along with the application of genomics in personalised medicine. Students will investigate the processes of manufacture, verification and validation testing to ensure regulations are met. The emerging area of cellular immunotherapy for cancer treatment will be discussed. Students will gain knowledge of the different types of therapies within this space. Case studies will be evaluated, including the challenges associated with bringing these therapies and devices to market. Classical formulations (i.e. oral, respiratory and injectable dosage forms) will be covered and advances within the field such as regulation of nanotechnology will also be discussed.

Unit details and rules

Unit code	PCOL5102
Academic unit	Pharmaceutical and Medical Device Development
Credit points	6
Prohibitions ?	None
Prerequisites ?	None
Corequisites ?	None
Assumed knowledge ?	None
Available to study abroad and exchange students	No

Teaching staff

Coordinator	Rania Salama, rania.salama@sydney.edu.au
Tutor(s)	Hui Ong, ong.hui@sydney.edu.au

Type	Description	Weight	Due	Length
Small continuous assessment	Short answer questions Written task	20%	Multiple weeks	6x 300 words each
Outcomes assessed:
Small test	Online quizzes MCQs	20%	Multiple weeks	10 minutes each
Outcomes assessed:
Presentation	Presentation and Peer Review 10% presentation, 5% peer review Please see Canvas for more information	15%	Multiple weeks	5 minutes
Outcomes assessed:
Assignment	Essay 1 Essay	15%	Week 04	1000 words
Outcomes assessed:
Assignment	Essay 2 Essay	15%	Week 07	1000 words
Outcomes assessed:
Assignment	Case study Please Canvas for details	15%	Week 09	1000 words
Outcomes assessed:

Assessment summary

Essays & Case study: Information will be provided with related questions for students to answer.
Short Answer Questions: Ensure the short answer questions are properly referenced.
Quizzes: online quizzes, each consisting of 5 multiple choice questions. Only one attempt at each quiz is allowed.
Presentation and Discussion: The presentation is to contain a voice over. Information about how to record will be provided. Students are expected to review their peers' presentations and participate in a discussion board, posting at least 2 comments on peer presentations.

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 (PCOL5102) the late submission penalty will be 5% of the maximum awardable mark for 5 calendar days only. 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: classical formulations and prescription medicines	Online class (10 hr)
Week 02	Module 1: classical formulations and prescription medicines	Online class (10 hr)
Week 03	Module 1: classical formulations and prescription medicines	Online class (10 hr)
Week 04	Module 2: medical devices	Online class (10 hr)
Week 05	Module 2: medical devices	Online class (10 hr)
Week 06	Module 2: medical devices	Online class (10 hr)
Week 07	Module 3: biologics and personalised medicine	Online class (10 hr)
Week 08	Module 3: biologics and personalised medicine	Online class (10 hr)
Week 09	Module 3: biologics and personalised medicine	Online class (10 hr)
Week 10	Module 4: manufacturing and safety of cell based products	Online class (10 hr)
Week 11	Module 4: manufacturing and safety of cell based products	Online class (10 hr)
Week 12	Module 4: manufacturing and safety of cell based products	Online class (10 hr)
Week 13	Module 4: manufacturing and safety of cell based products	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 basic principles underpinning innovative therapies and medical devices
LO2. Summarise the key regulatory requirements required in the development and registration of the different therapeutics and medical devices
LO3. Define the general processes of manufacture, verification and validation testing to meet regulation requirements
LO4. Evaluate the challenges associated with safety, manufacturing and production of medical devices and therapeutics
LO5. Understand the application of pharmacogenomics, pharmacodynamics and pharmacokinetics in development of modern therapeutics and personalised medicines.

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.

As a result of student feedback, we have increased the time limit for the Graded Quizzes from 7 minutes to 10 minutes. 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

Student hub - Professional Education in Health

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

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