Pharmaceutical and Medical Device Development

 

Pharmaceutical and Medical Device Development

Master of Medicine (Pharmaceutical and Medical Device Development)

Master of Science in Medicine (Pharmaceutical and Medical Device Development)

Students must complete 48 credit points, including:
(a) 12 credit points of compulsory units of study; and
(b) 24 credit points of stream specific units of study; and
(c) 12 credit points of stream specific or general elective units of study.

Master of Medicine (Advanced) (Pharmaceutical and Medical Device Development)

Master of Science in Medicine (Advanced) (Pharmaceutical and Medical Device Development)

Students must complete 60 credit points, including:
(a) 48 credit points of study as required for the Master of Medicine/Master of Science in Medicine
(b) 12 credit points of project units of study.

Graduate Diploma in Medicine (Pharmaceutical and Medical Device Development)

Graduate Diploma in Science in Medicine (Pharmaceutical and Medical Device Development)

Students must complete 36 credit points, including:
(a) 6 credit points of compulsory units of study; and
(b) 24 credit points of stream specific units of study; and
(c) 6 credit points of stream specific or general elective units of study.

Graduate Certificate in Medicine (Pharmaceutical and Medical Device Development)

Graduate Certificate in Science in Medicine (Pharmaceutical and Medical Device Development) (admission suspended)

Students must complete 24 credit points, including:
(a) 24 credit points of stream specific units of study.

Compulsory units

Compulsory units - Graduate Diploma, Graduate Diploma in Science

CEPI5100 Introduction to Clinical Epidemiology

Credit points: 6 Teacher/Coordinator: Dr Fiona Stanaway Session: Semester 1,Semester 2 Classes: Offered online (no fixed-time webinars) 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
Note: It is recommended that this is completed as soon as possible after enrolment into your first unit of study.
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 and screening; applicability of results to individual patients; and evidence-based use of health resources.
Textbooks
Online readings and resources to be provided on the eLearning website.

Compulsory units - Master of Medicine, Master of Science in Medicine, Master of Medicine (Advanced)

CEPI5100 Introduction to Clinical Epidemiology

Credit points: 6 Teacher/Coordinator: Dr Fiona Stanaway Session: Semester 1,Semester 2 Classes: Offered online (no fixed-time webinars) 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
Note: It is recommended that this is completed as soon as possible after enrolment into your first unit of study.
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 and screening; applicability of results to individual patients; and evidence-based use of health resources.
Textbooks
Online readings and resources to be provided on the eLearning website.
PCOL5104 Pharm and Medical Device Development

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong & Dr Rania Salama Session: Semester 2 Classes: online discussion forums, webinars Corequisites: CEPI5100 and 18 credit points of stream specific units of study from any of (PCOL5101, PCOL5102, PCOL5103, PCOL5105, PHAR7815) Assessment: 2 x 500 wd written assignments (10%), recorded presentation and peer review (20%), 2 x 3000 wd dossier sections submission and peer review (70%) Mode of delivery: Online
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).
Textbooks
Online readings and other learning resources will be provided

Stream specific units

PCOL5101 Drugs and Devices: R and D to Registration

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong & Dr Rania Salama Session: Semester 1 Classes: online lectures, podcasts, discussion boards, webinars Assessment: online quizzes (20%), short answer questions (20%) written assignments (30%), presentation (15%); case study (15%) Mode of delivery: Online
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.
Textbooks
online readings and other learning resources will be provided.
PCOL5102 Modern Therapeutics and Medical Devices

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong & Dr Rania Salama Session: Semester 2 Classes: online lectures, podcasts, discussion boards, webinars Assessment: online quizzes (20%), short answer questions (20%), written assignments (30%), case study (15%), recorded presentation and discussion (15%) Mode of delivery: Online
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.
Textbooks
online readings and other learning recourses will be provided.
PCOL5103 Therapeutics and Device Innovations (Project)

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong & Dr Rania Salama Session: Semester 1 Classes: online lectures, discussion forums & webinars. Corequisites: PCOL5101 or PCOL5102 Assessment: Record of Invention (15%), ethics protocols and peer review (30%), recorded presentation and peer review (20%), case study (15%), 510(k)/CA summary and peer review (20%) Mode of delivery: Online
This unit of study will provide students with the knowledge and skills to identify and evaluate complex technical problems and develop an implementation plan to address a problem. The unit will involve case studies from both pharmaceutical and medical device sectors, industry experts and application of international standards. Students will be given a problem from real life case studies and work through the steps to develop an implementation plan. In addition to submitting written reports, students will present their final implementation plan through recorded presentations.
Textbooks
Online readings and other learning resources will be provided
PCOL5105 Commercialising MedTech and Pharma

Credit points: 6 Teacher/Coordinator: Dr Rania Salama and Dr Hui Xin Ong Session: Semester 2 Classes: online lectures, podcasts, discussion boards, webinars, interactive media Assessment: online quizzes (20%), short answer questions/case studies (40%), written assignment(s) (40%) Mode of delivery: Online
This unit provides key business skills and related knowledge essential for the commercialisation of products in the medical device and pharmaceuticals sectors; from start-ups to large Pharma. The unit will provide students with a grounding in finance, human resources, market research and analysis, project management, risk management frameworks, regulatory and clinical strategy, freedom to operate and intellectual property. Students will learn how to develop a business case, based on market analysis, understand the process of capital fund raising and construct a development pathway for manufacturing and marketing of both medical devices and pharmaceutical products.
Textbooks
Online resources, readings and other learning recourses will be provided or accessible via the Library
PHAR7815 Regulation of Complementary Medicines

Credit points: 6 Teacher/Coordinator: Dr Joanna Harnett, Dr Rania Salama, Dr Hui Xin Ong Session: Semester 1 Classes: online lectures, podcasts, discussion boards, webinars, interactive media 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. Assessment: online quizzes (20%), short answer questions/case studies (40%), written assignment(s) (40%) Mode of delivery: Online
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.
Textbooks
Online resources, readings and other learning recourses will be provided or accessible via the Library

General elective units

BETH5104 Bioethics, Law and Society

This unit of study is not available in 2020

Credit points: 6 Teacher/Coordinator: Professor Roger Magnusson and Professor Cameron Stewart Session: Semester 1 Classes: 4x6.5hr 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.
BETH5104 Bioethics, Law and Society introduces students to some of the interrelationships between health care, ethics, and the law. Students will explore the moral basis of law and the means by which law in turn, influences and directs clinical practice and health policy. We also look at the limits of law in solving ethical dilemmas, and consider what happens when the law falls out of step with the moral institutions of health care providers, patients, and the general public. Over the course of the semester, students will learn 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 the law of consent, medical negligence, advance directives, maternal-foetal conflicts, abortion, reproduction, end-of-life decision-making, tissue regulation and infectious disease. Learning activities in BETH5104 include lectures, case discussions (during lectures), problem-based learning, online learning activities and written assessments.
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: Associate Professor Wendy Lipworth, Dr Narcyz Ghinea Session: Semester 2 Classes: 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%) 1 x minor essay (35%) 1 x 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.
Textbooks
Readings will be provided
BSTA5003 Health Indicators and Health Surveys

Credit points: 6 Teacher/Coordinator: Associate Professor Kevin MacGeechan Session: Semester 1 Classes: 8-12 hours total study time per week Corequisites: BSTA5001 Assessment: Assignments 100% (4 written assignments worth 25% each) Mode of delivery: Online
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.
CEPI5200 Quality and Safety in Health Care

Credit points: 6 Teacher/Coordinator: Professor Merrilyn Walton Session: Semester 1 Classes: Online Assessment: 3 x online quizzes and short response tasks (60%); 1 x 2000 word written assignment (40%) Mode of delivery: Online
Note: People working in health care will benefit from this course.
This course is specifically designed for health professionals who are working in health care. It will equip participants with underpinning knowledge about patient safety. The course modules cover quality and safety principles, professionalism and ethics, the blame culture, risk information, health care as a system, the impact of adverse events, methods to measure and make improvements in health care.
The modules, tools and the discussions are designed to enable participants to change behaviours by understanding the main causes of adverse events. The course provides foundation knowledge about quality and safety; governments around the world are concerned to address unsafe care. The course will better prepare health professional to understand the complexity of health care and take steps to minimise the opportunities for errors and address vulnerabilities in the system.
Textbooks
Runciman, Bill, Merry A Walton M. Safety and Ethics in Healthcare: A Guide to Getting it Right. 2007 Asgate Publisher.
CEPI5215 Writing and Reviewing Medical Papers

Credit points: 6 Teacher/Coordinator: Professor Angela Webster Session: Semester 1,Semester 2 Classes: 9 self-paced modules each comprising: course notes, lecture, demonstrations, exercises, quizzes Prerequisites: (PUBH5010 or CEPI5100) Prohibitions: CEPI5214 Assumed knowledge: Some basic knowledge of summary statistic is assumed Assessment: quizzes (30%), assignment 1 (20%), assignment 2 (50%) Mode of delivery: Online
Note: Students without the pre-requisites are encouraged to contact the Unit Coordinator to discuss their motivation and experience.
This unit of study will appeal to anyone wanting to write medical papers for conferences or journals, or to improve their paper writing skills. Students will work at their own pace through 9 modules covering research integrity, medical style, abstracts, presentations and posters, constructing a paper, data visualisation, manuscript submission, responding to reviewers' comments, post-publication research dissemination, and peer- reviewing a paper. This unit aims to teach students the principles of research integrity in writing for medical journals, typical issues they may face, and link to resources to help them maintain integrity through their publishing careers. It will guide them to reliable evidence-based resources to improve their conference abstract, presentation and poster design, and manuscript style and writing. Students will learn about reporting guidelines, common pitfalls in writing and presenting research, choosing a journal, keywords, improving tables and figures for manuscripts through open source software, copyright, writing cover letters and response letters to reviewers. Students will learn about measuring research impact and ways to improve research reach, dealing with the media and press releases, using social media in dissemination, digital archiving and basic skills needed to act as a peer-reviewer. This is an online unit, but those needing to study in block mode will do online study as well as a workshop.
Textbooks
Fayers P, Machin D. Quality of Life: The Assessment, Analysis and Reporting of Patient-reported Outcomes, 3rd Edition. 3 ed. Chichester, UK: Wiley Blackwell; 2016
CEPI5312 Diagnostic and Screening Tests (1 and 2)

Credit points: 6 Teacher/Coordinator: Dr Katy Bell Session: Semester 2 Classes: 1 x 2 hour synchronous seminar or asynchronous online tutorial/week for 12 weeks Prerequisites: PUBH5010 or CEPI5100 Prohibitions: PUBH5208 or CEPI5202 or CEPI5311 Assessment: Class discussion/presentations (40%) and two written assignments (60%) Mode of delivery: Normal (lecture/lab/tutorial) day, Online
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, and overdiagnosis. 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, and monitoring/surveillance. 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 readings will be provided.
CEPI5315 Introduction to Systematic Reviews

Credit points: 6 Teacher/Coordinator: Dr Sharon Reid Session: Semester 1 Classes: all students will work through four online-modules and participate in weekly online tutorials (asynchronously) or on-campus tutorials, depending on mode enrolled, over 12 weeks Corequisites: CEPI5100 or PUBH5010 Prohibitions: CEPI5203 or CEPI5102 or CEPI5314 Assessment: module assessment tasks (30%) and 1 x 4500 word assignment (70%) after the modules are completed Mode of delivery: Normal (lecture/lab/tutorial) day, Online
In this unit of study, we aim to introduce you to systematic reviews and meta-analyses of relevance to healthcare with a particular focus on systematic reviews of randomized controlled trials. Students can choose to learn in online or normal day (on-campus) mode. All students will work through four online modules, delivered over twelve weeks, addressing the following topics at an introductory level: What and why systematic reviews (and meta-analysis); How to formulate answerable healthcare questions and searching for systematic reviews; How a systematic review is conducted and understanding the principles of meta-analysis; and How to appraise, interpret and apply the results of systematic reviews (and meta-analyses). Students will have the opportunity to discuss unit of study learning materials in online tutorials or via weekly (on-campus) tutorials. Readings and other learning materials will be available via eLearning.
Textbooks
Readings and access to other learning resources are available through the unit's eLearning site
CLTR5001 Trial Design and Methods

Credit points: 6 Teacher/Coordinator: Rebecca Asher, Adrienne Kirby Session: Semester 1 Classes: discussion groups and problem based learning Assessment: 1 x short answer quiz (5%), 1 x peer review of an anonymised student's submission (5%),1 x online multiple choice quiz (5%), 1 x short answer (including calculations) quiz (5%), 2 x assignments with both short and long answer questions with calculations and diagrams (2 x 40%) 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: many available eg S Piantadosi, Clinical Trials A Methodological Perspective. KJ Rothman and S Greenland Modern Epidemiology. 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 Session: Semester 2 Classes: discussion groups and problem-based learning Prerequisites: CLTR5001 and CLTR5007 Assessment: 2x short answer, some calculations quizzes (2x10%), 2x long answer assignments (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 Health Systems and Financing

Credit points: 6 Teacher/Coordinator: A/Professor James Gillespie, Dr Carmen Huckel Schneider Session: Semester 1 Classes: Online students: 12 x week by week online tasks and activities (lectures, discussion boards, quizzes, short videos, interactive readings). Block Mode students: 2 x 2 full day workshops, plus 12 x week by week online tasks Prohibitions: GLOH5135 Assessment: compulsory contributions (5%), online quiz (15%), assignment 1: 2500 word individual written report on comparative health systems analysis (40%) assignment 2: 2500 word individual written report on analysis of health finance and policy objectives (40%) Mode of delivery: Block mode, Online
This unit aims to equip students with operational knowledge of the structures and financing of health systems. The focus will be on Australia and comparable countries. However, we will also look at particular issues around lower income and aid dependent health systems. Topics covered include funding priorities and mechanisms, the debates over the public-private mix, governance and accountability. The unit addresses questions such as: Who makes decisions about funding priorities? To whom should decision makers be held accountable and for what aspects of their work? How does health financing shape universal health coverage? By the end of this unit students will be able to: Apply a critical understanding of the basic history and features of the Australian and comparable health systems; Debate the main models and principles of health system funding, including principles of insurance, risk-pooling, equity, delivery and governance; Undertake a cross-country comparative analysis of health system features and outcomes, including low and middle income countries; Critically analyse national health budgets and funding programs; Locate finance policy in the wider context of health systems and economies.
Textbooks
Recommended: Blank, RH and Burau, V. Comparative Health Policy (5th Edition) Macmillan, 2017. (Readings are available on the unit's eLearning site)
HPOL5006 Business of Health

Credit points: 6 Teacher/Coordinator: A/Prof James Gillespie, Prof John Buchanan, Prof Shaun Larkin Session: Intensive July Classes: Block/intensive Mode - 4 days, 9am-5pm with preliminary online readings. Assessment: Online discussion participation (10%); online quiz (10%); 1 x 2000 word essay (30%); 1 x 3000 word research essay (50%) Mode of delivery: Block mode
Healthcare is now one of the largest employers and sectors in the Australian economy. Approximately two thirds of its funding comes from government, while two thirds of services are provided by the private sector. This unit explores this complex mix, building an understanding of the inter-relationships among the players in the industry, public and private. The course will explore the financial and regulatory environment in which providers operate and identify the main business models used by different players in the industry, including service providers, private insurers, employers, and government regulators. The unit draws on expert lecturers, international comparisons and case studies to give an understanding of the incentives and constraints that shape strategies to create value in health care. By the end of the unit students will: Have an understanding of the 'eco-system' of health care; Be able to navigate the regulatory and technological aspects of business in the health sector; Be able to identify and evaluate public and private business strategies and business plans in the main health care sectors.
Textbooks
Required and recommended readings and reference lists will be available through eLearning.
PUBH5018 Introductory Biostatistics

Credit points: 6 Teacher/Coordinator: Dr Timothy Schlub, Dr Erin Cvejic Session: Semester 1 Classes: 2 x 2hr lectures, 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%), 1x1hr online test (20%) and 1x1.5hr open-book exam (50%). 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 introduces students to statistical methods relevant in medicine and health. Students will learn how to appropriately summarise and visualise data, carry out a statistical analysis, interpret p-values and confidence intervals, and present statistical findings in a scientific publication. Students will also learn how to determine the appropriate sample size when planning a research study. Students will learn how to conduct analyses using calculators and statistical software.
Specific analysis methods of this unit include: hypothesis tests for one-sample, two paired samples and two independent samples for continuous and binary data; distribution-free methods for two paired samples, two independent samples; correlation and simple linear regression; power and sample size estimation for simple studies; and introduction to multivariable regression models;.
Students who wish to continue with their statistical learning after this unit are encouraged to take PUBH5217 Biostatistics: Statistical Modelling.
Textbooks
Course notes will be made available.
PUBH5422 Health and Risk Communication

Credit points: 6 Teacher/Coordinator: Dr Claire Hooker Session: Semester 1 Classes: Block/intensive: 2 x 2 days (9am-5pm each day); please check with the coordinator for scheduling Assessment: Assignment 1: 1 x 2500 word (35%), Assignment 2: 1 x 2500 words or equivalent (35%), online activities (30%). Attendance at the intensives is compulsory and 80% attendance is required to pass the unit of study. Mode of delivery: Block mode
In this unit, students learn how to communicate effectively with respect to health risks, both to individuals with health concerns, and with respect to risks to the public. 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, including: how to effectively manage outbreak or other crisis situations; how to communicate about issues where the risk is low but public concern is high (such as with respect to the fluoridation of water); and how to best manage controversies. 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.
WARC5001 Research Translation, Impact and Evaluation

Credit points: 6 Teacher/Coordinator: Prof Julie Redfern, Prof Clara Chow, Dr Stephanie Partridge Session: Semester 2 Classes: Online lectures, discussion forums, video tutorials Assumed knowledge: An understanding of research methodology and clinical trials is assumed. Assessment: Journal Club (30%); Discussion Boards (20%); Research Proposal (50%) Mode of delivery: Online
To optimise healthcare delivery, we need evidence-based strategies to enable research translation and to assess impact. This unit of study will teach these skills, including fostering and maintaining stakeholder engagement, pragmatic study design, cost effectiveness analysis, recognising and managing barriers and enablers to implementation, and post-research translation. Case-based discussions and preparation of a research proposal will develop the skills required to enhance impact and hasten adoption of research into routine care. This practical unit will suit students who are interested in improving their skills and knowledge in the areas of clinical or health services research and who are keen to enhance the impact of their current or future research.
Textbooks
Grol R, Wensing M and Eccles M. Improving Patient Care. The Implementation of Change in Clinical Practice. 2nd ed. Oxford: John Wiley & Sons, Incorporated (2013); Brownson RC, Colditz GA and Proctor EK. Dissemination and Implementation Research in Health: Translating Science to Practice. 2nd ed. New York, NY: Oxford University Press (2017).

Project units of study

MEDF5301 Project (Advanced Masters)

Credit points: 12 Teacher/Coordinator: Students must have a University of Sydney staff member or University approved supervisor for their project. Session: Semester 1,Semester 2 Classes: Students will be required to have regular contact with their supervisor to discuss the progress of their project. Assessment: 2000 word written project proposal (30%) and written final work of up to 10000 words, or a publication (as negotiated) (70%) Mode of delivery: Supervision
Note: Approval of the project and supervisor by the Program Director must be confirmed prior to commencing the project.
Candidates will work on an independent research project in an area of specific interest relevant to their master's degree. The project may take the form of analysis of an existing data set, a systematic or integrative review of the literature, a case series, survey or other project acceptable to the project supervisor. In some streams, projects may be available for students to select. It is essential, where there is the use of patient information or recruitiment of patient study subjects, that appropriate ethics approval is gained from the governing body where the project will take place. The candidate will enter into a learning contract and will be guided through the steps required to plan and execute a substantial research project, and prepare a scholarly work which may be a paper for publication. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.
MEDF5302 Project (Advanced Masters) (Part A)

Credit points: 6 Teacher/Coordinator: Students must have a University of Sydney staff member or University approved supervisor for their project. Session: Semester 1,Semester 2 Classes: Students will be required to have regular contact with their supervisor to discuss the progress of their project. Assessment: 2000 word written project proposal (30%) and written final work of up to 10000 words, or a publication (as negotiated) (70%) Mode of delivery: Supervision
Note: Approval of the project and supervisor by the Program Director must be confirmed prior to commencing the project.
Candidates will work on an independent research project in an area of specific interest relevant to their master's degree. The project may take the form of analysis of an existing data set, a systematic or integrative review of the literature, a case series, survey or other project acceptable to the project supervisor. In some streams, projects may be available for students to select. It is essential, where there is the use of patient information or recruitment of patient study subjects, that appropriate ethics approval is gained from the governing body where the project will take place. The candidate will enter into a learning contract and will be guided through the steps required to plan and execute a substantial research project and prepare a scholarly work which may be a paper for publication. Where appropriate students will prepare a work suitable for publication. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.
MEDF5303 Project (Advanced Masters) (Part B)

Credit points: 6 Teacher/Coordinator: Students must have a University of Sydney staff member or University approved supervisor for their project. Session: Semester 1,Semester 2 Classes: Students will be required to have regular contact with their supervisor to discuss the progress of their project Assessment: 2000 word written project proposal (30%) and written final work of up to 10000 words, or a publication (as negotiated) (70%) Mode of delivery: Supervision
Note: Approval of the project and supervisor by the Program Director must be confirmed prior to commencing the project.
Candidates will work on an independent research project in an area of specific interest relevant to their master's degree. The project may take the form of analysis of an existing data set, a systematic or integrative review of the literature, a case series, survey or other project acceptable to the project supervisor. In some streams, projects may be available for students to select. It is essential where there is the use of patient information or recruitment of patient study subjects that appropriate ethics approval is gained from the governing body where the project will take place. The candidate will enter into a learning contract and will be guided through the steps required to plan and execute a substantial research project and prepare a scholarly work which may be a paper for publication. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.