Pharmaceutical and Medical Device Development

 

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Unit of study descriptions


NB PCOL5104 Pharm & Medical Device Development (compulsory for Master’s students) and PCOL5103 Industrial therapeutics (project) will be available from Semester 2, 2018

BETH5104 Bioethics, Law and Society

Credit points: 6 Teacher/Coordinator: Dr Sascha Callaghan Session: Semester 1 Classes: 4x8hr intensives or online. Attendance is compulsory if enrolled in face-to-face block mode Assessment: 1x2000wd problem (40%); 1x3500 word essay (60%). Online 'attendance' is also compulsory and will be demonstrated by engagement in at least 8 out of the 10 weekly discussion topics. No formal mark will be given for attendance, but failure to meet the attendance requirement may result in failure of the course. Mode of delivery: Block mode, Online
Note: Prerequisites: A three-year undergraduate degree in science, medicine, nursing, allied health sciences, philosophy/ethics, sociology/anthropology, law, history, or other relevant field, or by special permission.
This unit of study begins by introducing students to intersections amongst health care practice, ethics, and the law. In particular students will explore the ethical and moral bases of law as well as how the law, in turn, influences moral norms, clinical practice, and health policy. Students learn how to critically read and analyse primary sources of law relevant to bioethics. Students will then examine a number of areas of law that have particular significance for bioethics and society including consent, tort law, competence, maternal-foetal conflicts, abortion, reproduction, mental health, end-of-life-decision-making, and genetics.
Textbooks
Required: Kerridge, Lowe and Stewart (2013), Ethics and law for the health profession, 4th Edition (Federation Press). All other compulsory readings are provided to students in digital format. Most supplementary readings can be accessed through the library collection.
BETH5209 Medicines Policy, Economics and Ethics

Credit points: 6 Teacher/Coordinator: Dr Wendy Lipworth Session: Semester 2 Classes: Block mode (2x2 days) and online or fully online Assumed knowledge: A degree in science, medicine, pharmacy, nursing, allied health, philosophy/ethics, sociology/anthropology, history, law, communications, public policy, business, economics, commerce, organisation studies, or other relevant field, or by special permission. Assessment: Online work (15%) 1x minor essay (35%) 1x major essay (50%) Mode of delivery: Online
Medicines save lives but they can be costly and can have serious adverse effects. Value-laden decisions are continuously being made at individual, institutional, national and international levels regarding the medicines we need, want and can afford. In this unit of study, we will explore and critique global and national policies and processes related to medicines, examining how research and development agendas are set; how medicines are assessed and evaluated; and how new technologies are translated into practice. We will also explore broader trends such as globalisation, commercialisation and changing consumer expectations. By the end of the course, students will understand the forces shaping the development, regulation, funding and uptake of medicines both nationally and internationally, and the political, ethical, legal and economic issues that are at stake. This course is designed to appeal to a wide range of students from ethics, law, public health, health care, policy, communications, economics, business, politics, administration, and biomedical science. Students will be encouraged to focus on issues of most relevance to their own area of study or work.
Textbooks
Readings will be provided
BSTA5003 Health Indicators and Health Surveys

Credit points: 6 Teacher/Coordinator: Dr Armando Teixeira-Pinto, University of Sydney Session: Semester 1 Classes: 8-12 hours total study time per week, distance learning Corequisites: BSTA5001 Assessment: 4 written assignments (20%, 30%, 25%, 25%) Mode of delivery: Distance education
On completion of this unit students should be able to derive and compare population measures of mortality, illness, fertility and survival, be aware of the main sources of routinely collected health data and their advantages and disadvantages, and be able to collect primary data by a well-designed survey and analyse and interpret it appropriately. Content covered in this unit includes: routinely collected health-related data; quantitative methods in demography, including standardisation and life tables; health differentials; design and analysis of population health surveys including the roles of stratification, clustering and weighting.
Textbooks
Paul S. Levy, Stanley Lemeshow, Sampling of Populations: Methods and Applications, 4th edition, Wiley Interscience 2008.
CEPI5100 Introduction to Clinical Epidemiology

Credit points: 6 Teacher/Coordinator: Dr Fiona Stanaway Session: Semester 1,Semester 2 Classes: Offered online and face-to-face (daytime tutorials) Prohibitions: PUBH5010 Assessment: Completion of online quizzes (15%), tutorial participation (10%), assignment 1 (15%), assignment 2 (60%) Mode of delivery: Normal (lecture/lab/tutorial) day, Online
This unit introduces the concept of clinical epidemiology and provides students with core skills in clinical epidemiology at an introductory level. Topics covered include asking and answering clinical questions; basic and accessible literature searching techniques; study designs used in clinical epidemiological research; confounding and effect modification; sources of bias; interpretation of results including odds ratios, relative risks, confidence intervals and p values; applicability of results to individual patients; critical appraisal of clinical epidemiological research literature used to answer questions of therapy (RCTs and systematic reviews), harm, prognosis, diagnosis, screening and clinical guidelines.
Textbooks
Online readings and resources to be provided on the eLearning website.
CEPI5200 Quality and Safety in Health Care

Credit points: 6 Teacher/Coordinator: Professor Merrilyn Walton Session: Semester 1 Classes: offered online Assumed knowledge: clinical experience strongly recommended Assessment: online participation (20%); 3x1000 word assignments and 1x1500 word assignment (80%) Mode of delivery: Online
The unit has four major content areas delivered as modules covering:- An understanding Q&S in Healthcare; Professional and ethical practice; Understanding systems and the effect of complexity on patient care; Improving Healthcare. At the end of the unit students will: understand the background to quality and safety in health care, from Australian and international perspectives; understand the nature of health care error including the methods of error detection and monitoring, and quality indicators; understand the role of good communication and other professional responsibilities in quality and safety in healthcare; have developed an understanding of clinical governance, accountability and systems management; have considered methods for improving healthcare such as getting research into practice, clinical practice guidelines and clinical practice improvement. This unit consists of online discussions and activities based around key provided readings and other resources.
Textbooks
Online readings and other learning resources will be provided.
CEPI5312 Diagnostic and Screening Tests (1 and 2)

Credit points: 6 Teacher/Coordinator: A/Prof Clement Loy Session: Semester 2 Classes: 1x2hr seminar/week for 12 weeks Prerequisites: PUBH5010 or CEPI5100 Prohibitions: PUBH5208 or CEPI5202 or CEPI5311 Assessment: Critical appraisal (10%), class discussion/presentations (40%) and two written assignment (50%) Mode of delivery: Online, Normal (lecture/lab/tutorial) evening
This unit of study introduces the student to basic concepts behind diagnostic and screening tests, including: test accuracy, sources of bias in test evaluation, critical appraisal of test evaluation studies, principles and use of evidence in making decisions about population screening. It will then move to more advanced topics including: application of test results to individual patients, place of tests in diagnostic pathways, impact of tests on patient outcome, tests with continuous outcome, receiver-operator characteristic curves, systematic review of diagnostic tests, predictive models, monitoring, diagnostic tests in the health system, and over-diagnosis. After completing this unit of study, the student should have a comprehensive understanding of contemporary issues and the methodology underlying, diagnostic and screening test evaluation and application.
Textbooks
Course notes will be provided
CLTR5001 Trial Design and Methods

Credit points: 6 Teacher/Coordinator: Adrienne Kirby, Emma Gibbs Session: Semester 1 Classes: discussion groups and problem based learning Assessment: 2x quizzes (2x10%), 2x assignments (2x40%) Mode of delivery: Online
This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaption of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5004 Advanced Trial Design

Credit points: 6 Teacher/Coordinator: Rachel O'Connell, Emma Gibbs Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 and CLTR5007 Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Mode of delivery: Online
Candidates will be taught skills to design and interpret equivalence trials, non-inferiority trials and cluster randomised trials. Specialised designs including enrichment and discontinuation designs will be discussed and special aspects relating to cross-over studies will be taught. Techniques to validly incorporate composite, co-primary and surrogate endpoints will be covered. Distinctions between event and chronological time directed outcomes will be discussed. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
HPOL5001 Economics and Finance for Health Policy

Credit points: 6 Teacher/Coordinator: A/Prof James Gillespie Session: Semester 1 Classes: Block mode with compulsory Intensive workshops on Campus. 2 x two day workshops plus online discussion Assessment: Health Economics Exercise (50%), Health finance assignment (50%) Mode of delivery: Block mode
This unit aims to provide students with an understanding of the main concepts and analytical methods of health economics, political economy and finance to examine the workings of health systems in Australia and comparable countries. Topics covered include the debates over the public-private mix and governance and accountability - who makes decisions about funding priorities? To whom should decision makers be held accountable and for what aspects of their work? How does health finance shape broader policy reform?
Learning outcomes: By the end of this unit students will be able to: (i) apply basic concepts and methodologies of health economics and political economy in policy analysis; (ii) understand the role of economic analysis in evaluating health policy change; (iii) understand the main models and debates regarding health system funding and the implications for equity, delivery and governance of health services; (iv) apply this knowledge to current Australian and global health systems and debates over reform; (v) be familiar with theoretical frameworks underlying health economics and current debates over health finance.
Textbooks
Buse K, Mays N, Walt G (2012). Making health policy. Second edition. Open University Press: London. Other required and recommended reading materials available from eLearning site.
MEDF5301 Project (Advanced Masters)

Credit points: 12 Session: Semester 1,Semester 2 Classes: Students will be required to have regular contact with their supervisor to discuss the progress and implementation of their project Assessment: 2,000 wd written project proposal (30%) and written final work of up to 10,000 wds, or a publication (as negotiated) (70%) Mode of delivery: Supervision
Note: Approval to enrol is conditional upon the submission of a brief project outline and identification of an appropriate project supervisor, as negotiated with the course coordinator.
Candidates will work on an independent research project in an area of specific interest relevant to their master degree. The project may take the form of a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. Candidates in some disciplines may be able to undertake a work placement and will be required to negotiate the form of scholarly written work, related to their placement, to be submitted for assessment. It is essential where there is the use of patient information or patient enrolment onto a study that appropriate ethics approval is gained from the governing body where the project will take place. On completion of the project/work placement the successful candidate will be able to plan and execute a substantial research project or scholarly work . Where appropriate students will prepare a work suitable for publication. A candidate must be enrolled in order to submit their project report/dissertation/publication. If the candidate cannot submit their work erolling once in MEDF5301 or once in both Part A and Part B then they must re-enrol in a minimum of six credit points of project units of study, with the concomitant financial liability, every semester until they submit.
MEDF5302 Project (Advanced Masters) (Part A)

Credit points: 6 Session: Semester 1 Classes: Students will be required to have regular contact with their supervisor to discuss the progress and implementation of their project Assessment: 2,000 wd written project proposal (30%) and written final work of up to 10,000 wds, or a publication (as negotiated) (70%) Mode of delivery: Supervision
Note: Approval to enrol is conditional upon the submission of a brief project outline and identification of an appropriate project supervisor, as negotiated with the course coordinator.
Candidates will work on an independent research project in an area of specific interest relevant to their master degree. The project may take the form of a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. Candidates in some disciplines may be able to undertake a work placement and will be required to negotiate the form of scholarly written work, related to their placement, to be submitted for assessment. It is essential where there is the use of patient information or patient enrolment onto a study that appropriate ethics approval is gained from the governing body where the project will take place. On completion of the project/work placement the successful candidate will be able to plan and execute a substantial research project or scholarly work. Where appropriate students will prepare a work suitable for publication. A candidate must be enrolled in order to submit their project report/dissertation/publication. If the candidate cannot submit their work erolling once in MEDF5301 or once in both Part A and Part B then they must re-enrol in a minimum of six credit points of project units of study, with the concomitant financial liability, every semester until they submit.
MEDF5303 Project (Advanced Masters) (Part B)

Credit points: 6 Session: Semester 2 Classes: Students will be required to have regular contact with their supervisor to discuss the progress and implementation of their project Assessment: 2,000 wd written project proposal (30%) and written final work of up to 10,000 wds, or a publication (as negotiated) (70%) Mode of delivery: Supervision
Note: Approval to enrol is conditional upon the submission of a brief project outline and identification of an appropriate project supervisor, as negotiated with the course coordinator.
Candidates will work on an independent research project in an area of specific interest relevant to their master degree. The project may take the form of a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. Candidates in some disciplines may be able to undertake a work placement and will be required to negotiate the form of scholarly written work, related to their placement, to be submitted for assessment. It is essential where there is the use of patient information or patient enrolment onto a study that appropriate ethics approval is gained from the governing body where the project will take place. On completion of the project/work placement the successful candidate will be able to plan and execute a substantial research project or scholarly work. Where appropriate students will prepare a work suitable for publication. A candidate must be enrolled in order to submit their project report/dissertation/publication. If the candidate cannot submit their work erolling once in MEDF5301 or once in both Part A and Part B then they must re-enrol in a minimum of six credit points of project units of study, with the concomitant financial liability, every semester until they submit.
PCOL5101 Drugs and Devices: RandD to Registration

Credit points: 6 Teacher/Coordinator: Prof Paul Young, Dr Hui Xin Ong, Prof Daniela Traini Session: Semester 1 Classes: Online lectures, podcasts, discussion boards, webinars, interactive media Assessment: Online quizzes (20%), 4xonline tutorial/workshops (60%), 1xfinal online exam (20%) Mode of delivery: Online
This course provides high level foundation knowledge of the process of translating a new drug, formulation and/or delivery device from a laboratory setting to a final approved product. This course is targeted at higher degree students in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. Specifically, the course covers 3-core areas (1) the regulatory system, (2) requirements during discovery, manufacture and clinical trials and (3) post-registration pharmacovigilance. 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 gain knowledge of international regulation, harmonisation and application to the Australian market. The course will cover RandD, manufacturing and clinical trial requirements. The concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD) as well as regulatory accepted laboratory methodologies used for submission of product dossiers. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics and clinical endpoints for registration of new products using case studies and workshops. Special requirements for the registration and testing of generic medicines will also be part of the course.
Textbooks
online readings and other learning recourses will be provided.
PCOL5102 Modern Therapeutics and Medical Devices

Credit points: 6 Teacher/Coordinator: Prof Paul Young, Dr Hui Xin Ong, Prof Daniela Traini Session: Semester 2 Classes: online lectures, podcasts, discussion boards, webinars, interactive media Assessment: online quizzes (20%), 4xonline tutorial/workshops (60%), 1xfinal online exam (20%) Mode of delivery: Online
This course develops knowledge in the area of current state-of-the-art-therapeutic technologies. The principles of operation and mode of action are investigated along with methods of manufacture and registration. This course is targeted at higher degree students in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. The course covers 4-core areas, reflecting different aspects of medicines regulation in Australia: (1) biologicals and personalised medicine, (2) Cell based products, (3) Medical devices and (4) classical formulations. The principles that underpin biologics are covered in terms of targeting and manufacture along with the application of genomics in personalised medicine. Students will investigate the processes of manufacture and regulation of vaccine medicines, including requirements for fast-tracking medicines. Cellular immunotherapy for cancer treatment is an emerging area. Students will gain knowledge of the different types of therapies within this space. Registration of medical devices will be covered. Specifically, each class of medical device (I-IV) will be studied using case studies and the challenges associated with bring these devices to market discussed. Classical formulations (i.e. oral, respiratory and injectable) will be covered and advances within the field such as regulation of nanotechnology discussed.
Textbooks
online readings and other learning recourses will be provided.
PUBH5018 Introductory Biostatistics

Credit points: 6 Teacher/Coordinator: Dr Kevin McGeechan and A/Professor Patrick Kelly Session: Semester 1 Classes: 2 x 2hr lecture, 10 x 1hr lectures, 11 x 2hr tutorials, 2 x 1hr and 8 x 0.5hr statistical computing self directed learning tasks over 12 weeks - lectures and tutorials may be completed online Assessment: Weekly quizzes (10%), 1x4 page assignment (20%) and 1x2.5hr open-book exam (70%). For distance students it may be possible to complete the exam externally with the approval of the course coordinator. Mode of delivery: Normal (lecture/lab/tutorial) day, Normal (lecture/lab/tutorial) evening, Online
This unit aims to provide students with an introduction to statistical concepts, their use and relevance in public health. This unit covers descriptive analyses to summarise and display data; concepts underlying statistical inference; basic statistical methods for the analysis of continuous and binary data; and statistical aspects of study design. Specific topics include: sampling; probability distributions; sampling distribution of the mean; confidence interval and significance tests for one-sample, two paired samples and two independent samples for continuous data and also binary data; correlation and simple linear regression; distribution-free methods for two paired samples, two independent samples and correlation; power and sample size estimation for simple studies; statistical aspects of study design and analysis. Students will be required to perform analyses using a calculator and will also be required to conduct analyses using statistical software (SPSS). It is expected that students spend an additional 2 hours per week preparing for their tutorials. Computing tasks are self-directed.
Textbooks
Course notes are provided.
PUBH5422 Health and Risk Communication

Credit points: 6 Teacher/Coordinator: Dr Claire Hooker, Associate Professor Julie Leask, Professor Phyllis Butow Session: Semester 2 Classes: Block/intensive 2 x 9-5 full days + 3 x 9-5 full days; please check with the coordinator for scheduling Assessment: Assignment 1 x 3000 word (50%), Assignment 1 x 2000 words (35%), online activities (15%). Attendance at intensives is compulsory and 80% attendance is required to pass the unit of study. Mode of delivery: Block mode
In this unit, students will develop a critical awareness of the determinants of effective communication, particularly in relation to health risks to the individual and to society. The first half covers individual health risk communication in clinical settings, including: theories of health communication, patient centred care and shared decision making; evidence-based communication skills; research paradigms including interaction analysis; cross-cultural communication in health care; discussing prognosis and informed consent. The second half explores risk communication for public health, ranging from managing outbreak situations to low risk / high concern issues such as immunisation. We teach theories of risk perception and communication with particular application to public health incident responses. We give practical guides to media messages, risk message framing, public engagement, traditional and social media, and the ethical aspects of public communication. The unit offers students the opportunity to learn from outstanding guest lecturers who work in these areas and interactive opportunities for students to try their skills in risk communication and decision making.
Textbooks
Students are provided with a list of readings (in digital format). Most supplementary readings can be accessed through the library or online.