PHAR7815: Semester 1, 2021

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Units PHAR7815 Semester 1 2021 [Online]

Unit of study_

PHAR7815: Regulation of Complementary Medicines

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

Overview

This unit provides a detailed overview of the processes involved in the development, production and regulation of complementary medicines and devices (with a focus on herbal and nutritional supplement products). In this unit, students will learn foundation concepts and principles of complementary medicines, the regulatory framework, relevant policies and ethical implications (including evidence claims) governing this industry, good manufacturing practice (GMP) and quality standards, submission of product dossiers requirements as well as internationalisation of complementary medicine products (e. g. regulation in Asia and other key areas for export). Students will gain an understanding of the processes and guidelines involved in registering complementary products with the Therapeutic Goods Administration (TGA) in Australia and will be able to assess the level and quality of evidence to support the manufacturer's claim. This unit is suitable for postgraduate students who are working in or interested in entering the complementary medicine development, manufacturing and regulation sector.

Unit details and rules

Unit code	PHAR7815
Academic unit	Pharmacy
Credit points	6
Prohibitions ?	None
Prerequisites ?	None
Corequisites ?	None
Assumed knowledge ?	Students will be expected to have a relevant health care, health science or science related undergraduate qualification or experience working in this sector.
Available to study abroad and exchange students	No

Teaching staff

Coordinator	Joanna Elizabeth Harnett, joanna.harnett@sydney.edu.au

Type	Description	Weight	Due	Length
Small test	Graded Quiz See Canvas for details	20%	Multiple weeks	4x 10 minutes
Outcomes assessed:
Online task	SAQs Short answer questions to cover content in modules 1, 2 and 3.	30%	Multiple weeks	3x 600 words
Outcomes assessed:
Assignment	CTD: Part 1 Draft of final written assignment.	5%	Week 08	1000 words
Outcomes assessed:
Assignment	CTD: Part 2 Draft of final written assignment	5%	Week 10	1000 words
Outcomes assessed:
Assignment	CTD: Part 3 Final submission, to include word count and feedback from Parts 1&2.	40%	Week 13	3000 words
Outcomes assessed:

Assessment summary

Graded Quizzes: there will be one quiz for each of the 4 modules, worth 5% each. Students are allowed one attempt only to complete the graded quizzes within the time limit.
SAQs: there will be an SAQ for Module 1, 2 and 3.
CTD Written Assignment: this will be split into 3 parts (2x 1000 word drafts and 1x 3000 final submission, including the word count and feedback from Parts 1 and 2).

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 (PHAR7815) 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: Foundational concepts and principles of complementary medicine	Online class (10 hr)
Week 02	Module 1: Foundational concepts and principles of complementary medicine	Online class (10 hr)
Week 03	Module 1: Foundational concepts and principles of complementary medicine	Online class (10 hr)
Week 04	Module 2: Regulatory framework for complementary medicine	Online class (10 hr)
Week 05	Module 2: Regulatory framework for complementary medicine	Online class (10 hr)
Week 06	Module 2: Regulatory framework for complementary medicine	Online class (10 hr)
Week 07	Module 3: Manufacturing & Regulatory standards (GxP)	Online class (10 hr)
Week 08	Module 3: Manufacturing & Regulatory standards (GxP)	Online class (10 hr)
Week 09	Module 4: Ethical requirements and Clinical Trials	Online class (10 hr)
Week 10	Module 4: Ethical requirements and Clinical Trials	Online class (10 hr)
Week 11	Module 4: Ethical requirements and Clinical Trials	Online class (10 hr)
Week 12	Module 4: Ethical requirements and Clinical Trials	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. Explain the regulatory framework for the assessment of safety, quality and efficacy of complementary medicines and devices
LO2. Discuss the key criteria for adherence to good manufacturing practice (GMP) standards
LO3. Develop high quality complementary medicines regulatory documentation
LO4. Evaluate the ethical aspects of complementary medicines marketing with a special focus on assessing the level and quality of evidence to support a complementary medicines product claim
LO5. Critically appraise the key differences between regulatory frameworks for complementary medicines within the global context.

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.

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

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