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Unit outline_

PCOL5101: Drugs and Devices: R and D to Registration

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

This unit of study provides a broad overview of the processes involved in translating a new drug, formulation and/or medical device from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical or medical device industries, and advisors in the regulatory sector. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery and device conception, manufacture and clinical trials, and (3) post-registration pharmacovigilance and pharmacoeconomics . Students will gain knowledge of the Therapeutic Goods Administration (TGA) and guidelines for the registration and regulation of medical devices and medicines. Students will also learn the importance of international regulations, harmonisation and application to the Australian market. The unit covers R and D; manufacturing and clinical trial requirements; the concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD); as well as regulator accepted laboratory methodologies used for submission of product dossiers and medical device documentation. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics, pharmacoeconomics and clinical endpoints for registration of new products using case studies and online tutorials. Special requirements for the registration and testing of generic medicines will also be part of the unit.

Unit details and rules

Academic unit Pharmacy
Credit points 6
Prerequisites
? 
None
Corequisites
? 
None
Prohibitions
? 
None
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Hui Ong, ong.hui@sydney.edu.au
Type Description Weight Due Length
Small test Graded quizzes
MCQ
20% Multiple weeks 7 minutes each
Outcomes assessed: LO1 LO6 LO5 LO4 LO3 LO2
Assignment SAQs
Written task
20% Multiple weeks 300 words each
Outcomes assessed: LO1 LO2 LO3 LO4 LO5 LO6
Assignment Essay 1
Essay
15% Week 04 1000 word
Outcomes assessed: LO3 LO4 LO2
Presentation Presentation
Recorded presentation
15% Week 08 5 minutes
Outcomes assessed: LO2 LO4 LO3
Assignment Case study
Case study
15% Week 10 1000 words
Outcomes assessed: LO2 LO3 LO5 LO6
Assignment Essay 2
Essay
15% Week 13 1000 words
Outcomes assessed: LO3 LO5 LO6

Assessment summary

  • Quizzes: Each of the topics in this unit of study includes an online graded quiz. Students are allowed 1 attempt only to complete the graded quizzes within the time limit. Each quiz consists of 5 MCQs. Some questions may have one single best answer, some may have multiple correct answers. For the latter type, this will be specified in the question stem.
  • SAQs: Student's answers must include proper referencing.
  • Presentation: A recorded PowerPoint presentation with voice over. Students are expected to review their peers' presentations and participate in a discussion board, posting at least 2 comments on 2 different peer’s presentations.
  • Essays: Students will be provided with a scenario with associated tasks.
  • Case study: Students will be provided with a short case study alongside related questions.

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 (PCOL5101) 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.

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.

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
Week 01 Module 1: the path to registration and production of pharmaceuticals Online class (10 hr)  
Week 02 Module 1: the path to registration and production of pharmaceuticals Online class (10 hr)  
Week 03 Module 1: the path to registration and production of pharmaceuticals Online class (10 hr)  
Week 04 Module 2: R and D dossier, documentation and manufacturing Online class (10 hr)  
Week 05 Module 2: R and D dossier, documentation and manufacturing Online class (10 hr)  
Week 06 Module 2: R and D dossier, documentation and manufacturing Online class (10 hr)  
Week 07 Module 3: requirements during discovery, manufacture, clinical trial and registrations Online class (10 hr)  
Week 08 Module 3: requirements during discovery, manufacture, clinical trial and registrations Online class (10 hr)  
Week 09 Module 3: requirements during discovery, manufacture, clinical trial and registrations Online class (10 hr)  
Week 10 Module 4: post-registration obligations Online class (10 hr)  
Week 11 Module 4: post-registration obligations Online class (10 hr)  
Week 12 Module 4: post-registration obligations Online class (10 hr)  
Week 13 Module 4: post-registration obligations 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 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. Summarise the processes and path for taking a new therapeutic or medical device from conception through to registration
  • LO2. Define the processes and steps that are required with respect to the local regulatory environment and how this differs from the requirements of overseas regulatory systems
  • LO3. Define the process requirements during discovery, manufacture, clinical trial and registration
  • LO4. Apply the principles of good record keeping in preparing an R and D dossier
  • LO5. Evaluate the ethical aspects of medicine and device marketing
  • LO6. Define the post registration obligations of registered products.

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 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.

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.