Outline

Overview

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 a 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, stability, safety, clinical trial or other suitable component of the process).

Unit details and rules

Academic unit	Pharmaceutical and Medical Device Development
Credit points	6
Prerequisites ?	None
Corequisites ?	CEPI5100 and 18 credit points of stream specific units of study from any of (PCOL5101, PCOL5102, PCOL5103, PCOL5105, PHAR7815)
Prohibitions ?	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
Presentation	Presentation & Peer Review 15% presentation 5% peer review See Canvas for details	20%	Multiple weeks	7 minutes + discussion board post
Outcomes assessed:
Assignment	Medical Device Market Authorization Document (Part B) Report 20% report 10% peer review See Canvas for details	30%	Multiple weeks	3000 words + discussion board post
Outcomes assessed:
Assignment	Common Technical Document (Part B) Report + Peer Review 20% report submission 10% peer review See Canvas for details	30%	Multiple weeks	3000 words + discussion board post
Outcomes assessed:
Assignment	Common Technical Document (Part A) Draft See Canvas for details	10%	Week 03	1500 words
Outcomes assessed:
Assignment	Medical Device Market Authorization Document (Part A) Draft See Canvas for details	10%	Week 09	1500 words
Outcomes assessed:

Assessment summary

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 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 (PCOL5104) 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.

Use of generative artificial intelligence (AI) and automated writing tools

You may only use generative AI and automated writing tools in assessment tasks if you are permitted to by your unit coordinator. If you do use these tools, you must acknowledge this in your work, either in a footnote or an acknowledgement section. The assessment instructions or unit outline will give guidance of the types of tools that are permitted and how the tools should be used.

Your final submitted work must be your own, original work. You must acknowledge any use of generative AI tools that have been used in the assessment, and any material that forms part of your submission must be appropriately referenced. For guidance on how to acknowledge the use of AI, please refer to the AI in Education Canvas site.

The unapproved use of these tools or unacknowledged use will be considered a breach of the Academic Integrity Policy and penalties may apply.

Studiosity is permitted unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission as detailed on the Learning Hub’s Canvas page.

Outside assessment tasks, generative AI tools may be used to support your learning. The AI in Education Canvas site contains a number of productive ways that students are using AI to improve their learning.

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
Multiple weeks	Module 3: Tomorrow's therapies and devices	Online class (10 hr)
Week 01	Module 1: Regulatory submission for pharmaceutical products	Online class (10 hr)
Week 02	Module 1: Regulatory submission for pharmaceutical products	Online class (10 hr)
Week 03	Module 1: Regulatory submission for pharmaceutical products	Online class (10 hr)
Week 04	Module 1: Regulatory submission for pharmaceutical products	Online class (10 hr)
Week 05	Module 1: Regulatory submission for pharmaceutical products	Online class (10 hr)
Week 06	Module 1: Regulatory submission for pharmaceutical products	Online class (10 hr)
Week 07	Module 2: Regulatory submission for medical devices	Online class (10 hr)
Week 08	Module 2: Regulatory submission for medical devices	Online class (10 hr)
Week 09	Module 2: Regulatory submission for medical devices	Online class (10 hr)
Week 10	Module 2: Regulatory submission for medical devices	Online class (10 hr)
Week 11	Module 2: Regulatory submission for medical devices	Online class (10 hr)
Week 12	Module 2: Regulatory submission for medical devices	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. 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
Learning outcomes

Responding to student feedback

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

Since the last time this unit ran in 2019, the assessments have been modified to allow students to submit a draft version of the final dossier and receive feedback before submitting the final version later in semester. Assessment weightings have also been modified to highlight the importance of peer review components. 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

On this page

Useful links

PCOL5104: Pharm and Medical Device Development

Semester 2 Early, 2020 [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