This online unit with an optional face-to-face component 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.

This online unit with an optional face-to-face component 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.

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

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.

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. 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. 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.

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.

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.

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.

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 maternalfoetal conflicts abortion reproduction endoflife decisionmaking tissue regulation and infectious disease Learning activities in BETH5104 include lectures case discussions during lectures problembased learning online learning activities and written assessments

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.

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.

This course is specifically designed for health professionals 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 behaviour 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 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.

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.

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, application of test results to individual patients, place of tests in diagnostic pathways, impact of tests on patient outcomes, principles and use of evidence in population screening, overdiagnosis, systematic review of diagnostic tests and meta-analysis. 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.

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.

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 adaptation 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.

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.

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.

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.

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.

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.

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. 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. 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. Approval of the project and supervisor by the Program Director must be confirmed prior to commencing the project.