Candidates will work on an independent research project in an area of specific interest. The project may take the form of analysis of an existing data set, a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. 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. Approval of the project and supervisor by the Program Director must be confirmed prior to commencing the project. The candidate will be guided through the steps required to plan and execute a substantial research project and prepare 1 or 2 papers acceptable for publication in a peer reviewed journal. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.

Candidates will work on an independent research project in an area of specific interest. The project may take the form of analysis of an existing data set, a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. 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. Approval of the project and supervisor by the Program Director must be confirmed prior to commencing the project. The candidate will be guided through the steps required to plan and execute a substantial research project and prepare 1 or 2 papers acceptable for publication in a peer reviewed journal. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.

Breast surgery requires comprehensive knowledge of the basic sciences of the breast and also the various elements of benign breast diseases. This unit of study aims to prepare candidates for a career in breast surgery. The unit focuses on:
1. the anatomy of the breast, axilla and donor sites for reconstruction flaps
2. anatomical variations and physiological changes in the breast and axilla
3. benign breast diseases including mastitis, mastalgia, nipple discharge and aberrations of normal development and involution (ANDI)
4. current radiological modalities in breast disease imaging and risk assessment for patients
5. genetic and non-genetic risk assessment for patients
6. the importance of oestrogen and HER 2 receptors in breast cancer.

Breast surgery requires a thorough knowledge of the science and management of malignant breast disease and this unit of study aims to prepare the post fellowship candidate for a career in breast surgery. The content focuses on the pathology and recent advances in the understanding of the pathogenesis of malignant breast disease. You will gain an indepth understanding of available prognostic assessment tools, multidisciplinary care of breast cancer patients ( including adjuvant and neoadjuvant chemotherapy, radiotherapy, endocrine therapy and the integral role of the breast care nurse and other allied health staff) and survivorship issues. Specific surgical decision algorithms and surgical options for malignant and insitu disease will be thoroughly explored and explained.

Breast surgery requires a thorough knowledge of the science and management of malignant breast disease and this unit of study is aimed at post-fellowship training (PFT) candidates committed to a career in breast surgery. You will focus on principles of oncoplastic breast surgery techniques used to extend the role of breast conservation and improve the aesthetics of breast conservation surgery. Techniques of volume displacement, mammoplasty, volume replacement, symmetry procedures and good mastectomy technique are covered. You will develop your clinical judgement regarding the use of different techniques and how they are integrated with the multidisciplinary management of breast cancer.

This unit of study concludes the specialist breast surgery curriculum. The focus is on breast reconstruction after mastectomy. It includes the full range of breast reconstruction techniques - implant based reconstruction, latissimus dorsi reconstruction and free flap tissue options ¿ as well as lipofilling and nipple reconstruction techniques. Students will participate in multi-surgeon meeting case discussions with complex decision-making and management of complications.

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.

In this unit of study, the student will develop his/her own research proposal, to a standard suitable for a peer-reviewed granting body. Each section of a grant proposal (Abstract, Aims, Background, Significance, Methods) will be discussed, with the student presenting and refining the corresponding section of his/her own proposal in a synchronous online workshop setting. This will be complemented by online presentations from experienced researchers on the practical aspects of clinical research. Topics include: observational studies, randomised controlled trials, diagnostic test evaluation, qualitative studies, economic evaluation, and process evaluation. The unit will conclude with a one-day, face-to-face, mandatory workshop where students will learn about budgeting, qualitative research, strategies and grant administration, research ethics and peer review of research grants.

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.

Recent major advances in understanding of the human genome and the relationship between genetic variation and disease have changed clinical practice. This unit provides contemporary knowledge of genetic disease, diagnosis, genomic testing, prognosis, management, inheritance and impact across a range of chromosomal, single gene and heterogeneous genetic conditions. You will study common conditions, such as intellectual disability, inherited cancer, and paediatric and adult-onset disorders, as well as genomic mechanisms and genetic variations which lead to human disease. A case based approach will be used to develop skills in interpretation of clinical, family history and genomic test results to formulate an appropriate diagnosis and accurate genetic risk information. Ethical issues in genomic medicine will also be considered. Advances in treatments for genetic diseases will be explored, along with possible uses and limitations of new technologies, including genome editing approaches. The RACP Clinical Genetics Advanced Training Committee has approved this unit to fulfill the Genetics University Course Requirement for advanced training in Clinical Genetics. It is suitable for all practitioners who require a working knowledge of genomics in clinical practice.

Thrombosis and haemostasis affect all areas of clinical practice. This unit of study will familiarise students with normal and pathological haemostasis, interpretation of coagulation laboratory tests, and practical management of bleeding and clotting disorders in the perioperative and critical care setting. Case-based discussions will explore strategies for diagnosis, investigation and management in theatres, ICU and the emergency department to assist in making optimal clinical decisions.

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.

Many issues have been identified that are of potential relevance for planning, implementation and execution of an evaluation study in the health and technology innovations. This unit aims to address issues covering all phases of an evaluation study: Preliminary outline, study design, operationalization of methods, planning, execution and completion of the evaluation study. Students completing this unit will have better insights leading to a higher quality of evaluation studies for health technology solutions.
This unit is an important component towards building stronger evidence and thus to progress towards evidence-based health solutions and technology innovations.
Graduates of this unit of study will have a strong interdisciplinary knowledge base, covering diverse areas such as health, economics, health technologies, health informatics, social science and information systems.
Topics areas covered: 1. Economic Aspects of Health Technology Evaluation; 2. The Development of Health Technologies and Health Informatics Evaluation; 3. The Role of Evaluation in the Use and Diffusion of Health Technology.

This unit will provide a foundation for further study in health law by examining laws that govern the liability of health professionals across a range of fields (eg criminal law, torts, contract, discrimination law) and mechanisms for the oversight and disciplining of health professionals. The unit will explore the role of law as a means to regulate/set limits on the conduct of health professionals and examine debates about the proper role of law in regulating the provision of health care. It will also critically evaluate law reform initiatives with respect to legal liability, complaints mechanisms and disciplinary action against health professionals where relevant. Topics to be covered may include: Legal and non-legal methods of regulating the practices of health professionals; the limits imposed on health professionals by the criminal law; the principles of negligence and their application to the liability of health professionals; contractual and fiduciary duties of health professionals; liability of hospitals; discrimination in health care; procedures for complaints against health professionals; disciplinary proceedings and the statutory reporting obligations of health professionals.

This unit of study will focus on the practice and procedure of class actions, which have emerged as the fastest growing species of litigation in Australia. Students will review the threshold requirements of commencing a class action, the processes by which class actions are brought to mediation and trial, and the perspectives of plaintiffs, defendants and third party litigation funders. The intersections of the legal and economic aspects of class actions will be considers in the context of a variety of species of this litigation, including shareholder, consumer, product liability, mass torts, environmental and cartel conduct claims. Students will review the relevant state and federal legislation governing class actions and case law that has developed in this area, together with developing a real-world practical understanding of how this litigation is conducted before the Courts.

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 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 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.

In this unit, you will learn how to analyse health data using statistical models. In particular, how to fit and interpret the results of different statistical models which are commonly used in medicine and health research: linear models, logistic models, and survival models. This unit is ideal for those who wish to further develop their research skills and/or improve their literacy in reading and critiquing journal articles in medicine and health.
The focus of the unit is very applied and not mathematical. Students gain hands on experience in fitting statistical models in real data. You will learn how to clean data, build an appropriate model, and interpret results. This unit serves as a prerequisite for PUBH5218 Advanced Statistical Modelling.

This unit is designed to encourage students to consider the role and significance of leadership in various organisational contexts. The unit introduces the major streams of leadership theory and traces the development of our understanding about leadership. The unit explores how these theories allow us to understand leadership in practice and in what ways leadership is linked to different aspects of organisational effectiveness. It then examines the 'good, the bad, and the ugly' sides of leadership, e.g. positive forms (transformational, charismatic) and negative forms (narcissistic and Machiavellian). The unit explores leading for diversity and diversity in leadership (e.g. based on gender, culture and ethnicity) and the role of leaders in constituting ethical and socially responsible organisations. The critical role of leaders in effecting organisational change is explored and the leadership of top management teams and leadership succession is examined. The unit also examines leadership development programs and instruments and students have an opportunity to reflect on factors that might influence their own leadership style.