Professional Development Presenter Profiles
Our experienced presenters are talented experts in their field and are widely acknowledged by their peers. They have been specially selected to meet a range of learning needs, ensuring a full experience for the participant in a supportive learning environment.
Below are biographies of each presenter.
|
Presenter: Gary Burgess Gary Burgess is a qualified biomedical engineer who has spent several years in the private sector developing electronic equipment and medical devices, before moving to Canberra to join the TGA as a medical device assessor. Gary has six years experience at the TGA dealing with conformity assessments of medical device manufacturers. He has attended QMS audits of manufacturers as a technical specialist, and has represented the Australian regulator on Study Group 1 of the Global Harmonization Task Force (GHTF), which is concerned with pre-market evaluation of medical devices, including conformity assessment. Gary is currently the Director of the Conformity Assessment section in the Office of Devices Authorisation (ODA) at the TGA. |
|
Presenter: Margaret Butler Margaret Butler is a registered nurse whose qualifications include Perioperative Certificate, Bachelor of Nursing and Master Adult Education. Margaret is a Perioperative Nurse Educator in the Operating Suite of St Vincent's Hospital, Sydney. In this role she coordinates several perioperative nursing education programs including the Perioperative Nursing Clinical Program, which includes students from St Vincent's Hospital and St Vincent's Private Hospital operating suites. Margaret is also an Honorary Clinical Fellow of the Australian Catholic University School of Nursing (NSW & ACT) and is the Coordinator of Perioperative & Anaesthetic and Recovery Room Specialty Practice Units for the ACU National Master of Health Science - Clinical Practice. |
|
Presenter: Stefan Czyniewski Graduating with a bachelor degree in Medical Science from the University of Sydney in 2000, Stefan worked as a research assistant for an orthopaedic surgeon, primarily on hip and knee resurfacing prosthesis and autologous chondrocyte implanting in post market research. In 2003, Stefan joined the clinical research team at Fornier Pharma (now Solvay Pharmaceuticals/Abbott) and was based at the Clinical Trial Centre at the NHMRC. Stefan worked as a clinical research associate and data manager on the FIELD study, a multi-centre, international, phase III study. His role at the clinical trials centre included project management for Australian and New Zealand clinical sites, coordinator of a cardiovascular sub-study and assisting with laboratory data processing. In 2006, Stefan moved back into the device space working as a Senior Clinical Research Associate at Ventracor. Stefan was placed in charge of the clinical dossier for CE Marking of the VentrAssist, which was achieved in December 2006. In 2007 Stefan was promoted to Clinical Affairs Manager at Ventracor and continued this posting until 2009. Stefan is a founding member of Mobius Medical and is the company’s Clinical Affairs Director. Stefan brings with him a sound knowledge and experience of clinical trial management and regulatory report submission requirements required for device approval. His experience includes clinical trial design, database design, project management and regulatory reporting requirements. |
|
Presenter: Dr Martin Devitt Dr Martin Devitt graduated with a Bachelor of Medicine from the University of Newcastle (Australia) in 1997. He initially became a registrar in anaesthetics and intensive care, but in 2000 joined the Therapeutic Goods Administration (TGA), a statutory body of the Australian Government that regulates the supply of therapeutic goods (medical devices, medicines, etc.) in Australia. As Head of the Clinical Section in the Office of Devices, Blood and Tissues, his role included the provision of high level advice on clinical considerations in the regulation of medical devices; participation on the TGA’s Medical Devices Expert Committee (MDEC) and Medical Device Incident Review Committee (MDIRC); the development of legislation and policy initiatives both nationally and internationally, including input into the workings of the Global Harmonisation Task Force (GHTF); participation as a member on a committee of Standards Australia; and the auditing of quality management systems to ISO 13485. In 2005, he joined Cook Australia to undertake the position of Medical Director in a global capacity, providing high-level clinical advice on pre- and post-market safety, quality, performance, and marketing issues pertaining to the manufacture and supply of medical devices globally. Martin is a founding member of Mobius Medical and is the company’s Medical Director. He brings medical devices experience from both the regulator and the industry. His expertise encompasses clinical and regulatory input into all aspects of medical device research and development, manufacturing, and commercialisation, including clinical trials, clinical evidence, and post-marketing issues; health technology assessment of medical devices for reimbursement; and quality management system auditing to ISO 13485 and clinical trial auditing to ICH GCP. Martin has successfully completed the Company Directors Course (CDC) through the Australian Institute of Company Directors (AICD) and is a Director on a number of Boards. He is able to provide corporate advisory services to companies pursuing the commercialisation of medical devices. Martin also practices emergency medicine part-time. |
|
Presenter: Sue Driscoll Sue Driscoll is the Chief Executive Officer of Health Communications, an associate of Victorian Hospitals Industrial Association. Health Communications specialises in providing public relations and marketing support to the Australian health care sector. Her clients include all areas of healthcare: metropolitan and rural hospitals, aged care and disability agencies, mental health support, community health, health partnerships, general practice organisations and disease-specific support groups. Sue is an experienced practitioner who worked in major metropolitan Melbourne hospitals and Victorian health agencies for around 20 years. During this time she coordinated hospital and network responses to major crises including infection outbreaks, industrial action, coronial inquests, funding shortfalls, facility and equipment malfunctions and the many media stories – good and bad news – that face a Victorian public hospital. She has taught strategic communication planning and community relations to Masters students, as well as writing and editing courses at undergraduate and postgraduate levels. In addition she has provided industry training for health and PR managers on communication planning, issues and crisis management – and of course media management. An ex-journalist, she is a former President of the Public Relations Institute of Australia (Victoria), organised the Institute’s last two overseas study tours (to the US and UK) and has been a regular commentator on public relations and communications on ABC Radio. |
|
Presenter: Alan Edgecomb Alan Edgecomb has more than 30 years experience in the medical device industry. Alan has worked as a service engineer for Siemens Medical Systems and Philips Medical in South Africa and for General Electric Medical Systems in Australia. Alan was the Quality and Regulatory Affairs Manager for the South East Asia region of General Electric Medical Systems, the Quality and Service Manager for an Australian start-up company, ImpediMed Limited, and currently is the Quality and Regulatory Affairs Manager for Abacus ALS in Brisbane. Alan also provides consulting services to various medical device companies in Brisbane. Alan has been involved with ISO 9001 and ISO 13485 quality management systems for the last 15 years having implemented and managed QMS at various sites in Australia. Alan has been running QMS training courses for the past 8 years. |
|
Presenter: Stephen Greaves An award winning (2001 Prime Ministers Award for Business and Community Partnerships) business professional, Stephen Greaves is a Partner of Two + You Leadership Design, a leadership design consultancy firm based in Melbourne. |
|
Presenter: Alina Hughes Alina Hughes joined MTAA in 2010 and is the Code of Practice Manager. Alina has worked in the field of corruption prevention, ethics and compliance since 2004. After graduating from the University of New South Wales with a Bachelor of Arts and Bachelor of Laws, Alina initially worked as a solicitor for Minter Ellison Lawyers in Sydney. From 2003-08, Alina worked for the NSW Independent Commission Against Corruption, firstly in the Complaints Assessment area and then in the Corruption Prevention, Education and Research Division. From 2008-10 she worked in the Corruption Prevention Unit at RailCorp. In 2010, she rejoined the ICAC on a temporary basis to work on an inquiry that it was holding into lobbying. Alina has provided advice and training on ethics and compliance issues to a wide range of audiences. In 2007, she presented a paper at the Australian Public Sector Anti-Corruption Conference. Alina also holds a Master of Laws from the University of Sydney. |
|
Presenter: Helen Kierce Helen Kierce manages the Training Services Unit at the Victorian Hospitals Industrial Association (VHIA). She has over 13 years experience as a manager, consultant and trainer in the field of professional, personal and workplace based training. Helen’s current role involves leading the development the VHIA’s training program, including overseeing the strategic direction and expansion of the training business to meet the needs of the members of the Association. She manages a small team of full-time staff supplemented by a broad range of associate trainers and training partners. Helen graduated with a Bachelor of Economics Degree from Monash University in 1983 and has since completed a Graduate Diploma of Business (Organisational Behaviour), a Master of Professional Education; and Training and a Certificate IV Training and Assessment. Helen’s focus is on devising relevant, responsive and engaging professional development programs that enable employees and managers to reach their full potential at work. |
|
Presenter: Michelle Loth Michelle Loth has worked as a registered nurse in operating theatres for over 10 years. Her qualifications include Bachelor of Nursing, Graduate Certificate in Nursing (Perioperative) and Certificate IV in Workplace Training & Assessment. Michelle has worked at the Royal Brisbane & Women's, Holy Spirit Northside and The Prince Charles Hospitals. She has experience in elective and emergency surgery, particularly focusing in the speciality areas of urology, vascular and burns. She has worked in a variety of roles including registered nurse, clinical nurse, clinical pathways project manager and nurse educator. Currently, she is the Perioperative and Procedural Areas Nurse Educator at The Prince Charles Hospital, Chermside. Her role includes the education of staff within the operating theatre, recovery, sterilising department and endoscopy unit as well as corporate education for all hospital staff. |
|
Presenter: Merv Neal Merv Neal has owned and operated his own businesses for more than 30 years and is presently the CEO of Laughteryoga International. He is an Associate Fellow of the Australian Institute of Management and an Affiliate Member of the National Speakers Association, where he received the Mentor of the Year for 2004, and Speaker of the Year nominee for 2006. Merv now spends his time as a professional speaker, trainer and facilitator in the areas of strategic business planning, leadership, culture and stress management. |
|
Presenter: Dr Patricia Nicholson Patricia Nicholson comes with a wealth of experience in perioperative nursing and education. She coordinates the Master of Advanced Nursing Practice Degree at the University of Melbourne's School of Health Science. Patricia teaches across a range of nursing subjects, including perioperative nursing and midwifery. Patricia is an Executive member of the Victorian Perioperative Nurses Group. She was the Victorian representative on the Australian College of Operating Room Nurses Board for 4 years. During this time she chaired the review of the 2010 – 2011 ACORN Standards. Patricia has recently completed her PhD in education, which was focused on the development and validation of clinical competencies. |
|
Presenter: Dr Sue O’Malley Dr O’Malley is the principal consultant and founder of Medical Intelligence, a consulting business specialising in all areas of Australian health technology assessment (HTA) excluding pharmaceuticals. In recent years Medical Intelligence has become one of the few specialist consultancies covering reimbursement for surgical, diagnostic and pathology procedures, medical devices and prostheses. Sue submitted her first application to the Medical Services Advisory Committee (MSAC) for Medicare Benefits Schedule (MBS) funding in 1999 and by 2011 has been involved in more applications than any other individual. She has also submitted numerous applications to the Prostheses and Devices Committee (PDC), now Prostheses List Advisory Committee (PLAC) for the funding of a wide variety of prostheses through listing on the Prostheses List. Dr O’Malley started as a Health Economist in 1993 as Principal Economist for the Northern Sydney Area Health Service. This appointment followed several years working as a senior public servant working as both an Economist and a Policy Coordinator. Since starting in the Health Industry she has worked in biotechnology, pharmaceutical and medical devices companies. She holds a Masters Degree in Public Economics and has recently been awarded a Doctorate of Philosophy based on a thesis by publication titled “Funding issues of new and emerging medical technology in Australia.” |
|
Presenter: Anna Pannuzzo Anna Pannuzzo is the Senior HR Consultant and Manager of the HR Services Unit at the Victorian Hospitals Industrial Association (VHIA). In addition, Anna delivers training on a number of VHIA’s core HR and Management courses. She brings to her training and consulting over 20 years experience in senior Human Resource roles. Prior to joining VHIA, Anna worked in Aged aged care, health and community services, local government, TAFE, higher education and the Accident Compensation Commission. Anna has a Diploma of Science Nursing, Bachelor of Business (Human Resources and Industrial Relations) and Certificate IV Training and Assessment. She is a member of the Australian Human Resources Institute and an Associate Fellow of the Australian College of Health Service Executives. |
|
Presenter: David Ross David Ross is the Director, Healthcare Access at MTAA. His role is to encourage the development of strategies to improve patient access to new medical technology. Since joining the industry association in 2001, he has been heavily involved in providing industry’s input to proposed reforms of prostheses benefits arrangements leading to the current Prostheses List arrangements. He has also participated in preparation of the MTAA’s submissions to the Government’s Health Technology Assessment Review. David was a member of the Prostheses and Devices Committee from its inception in 2004 to its last meeting in June 2010. He is a member of the Prostheses List Advisory Committee. His first career was in the Australian Army where he experienced a range of staff, regimental and training appointments in Australia and overseas. He has an MBA from Southern Cross University, has been a board member of Research Australia and is currently on the board of Sunshine Homes. |
|
Presenter: Ece Smrdelj Ece Smrdelj has over 20 years experience in the pharmaceutical and medical device industries having worked both locally and internationally. Ece's expertise is in quality assurance, validation, training, new product registration and introduction, pre approval inspections, vendor inspections and manufacturing including API, biologics and sterile and non-sterile dosage forms. She has wide experience in quality management system development, implementation and improvements, device conformity assessment, ISO 13485 implementation GAP analysis, design control and training in Australia & SE Asia. |
|
Presenter: Cliff Spong Cliff Spong joined MTAA in late 2005 and is Director of Regulatory and Scientific Affairs. Cliff has a Bachelor of Engineering and Master of Biomedical Engineering degrees from the University of New South Wales. He is a Fellow of the Institution of Engineers Australia. Following his Masters degree, Cliff established the first rehabilitation engineering department in a public hospital in eastern Australia at Royal South Sydney Hospital in conjunction with the University of New South Wales. During this time he also lectured in post graduate biomechanics at the University. After working for Telectronics as Head of the Biomechanical Research Group; and Telstra, in the areas of occupational health and safety and risk management, Cliff moved to the Therapeutic Goods Administration where he spent 12 years in various senior positions in the medical devices regulatory program. |
|
Presenter: David Strangward David Strangward has consulted to many of Australia's largest organisations in banking, insurance, mining, training, telecommunications in a variety of roles from project management, large IT systems implementation, customer relationship management and training. David has extensive and varied business, IT and training experience. He is a CEO and Managing Director of two organisations and in these roles uses his extensive leadership and management skills while focusing on: His leadership skills, team focus and integrity continue to earn him the respect of his colleagues and clients. |
|
Presenter: Louise White Louise White has over 20 years experience in the biotech and pharmaceutical industries in sterile manufacturing, Quality Assurance and Consulting. Louise has provided QA oversight over a variety of validation projects as well as preparing validation documentation associated with many capital works projects. She has conducted GMP compliance audits and gap analysis for international companies. Louise has developed many GMP training courses including self-paced computer-based training. Louise's areas of expertise include GxP training program development and delivery, FDA/TGA and EU cGMP compliance and gap analysis, quality management systems and validation across devices, pharmaceuticals and biologics. |
|
Presenter: Suzanne M. Williams Suzanne M. Williams studied Applied Biological Science at Manchester University in the UK graduating in 1993. Suzanne joined ICON Clinical Research (UK), as a Clinical Research Associate, enjoying exposure to many therapeutic areas within the pharmaceutical clinical trials arena. Following a year sabbatical in their Chicago office, and armed with a sound understanding of FDA as well as European regulations, Suzanne moved to Australia to help establish ICON’s new Sydney office in 1997. She went on to gain extensive experience of ‘big pharma’ clinical trials management at Searle, Pharmacia and Pfizer. In 2003, Suzanne set up a consulting business independently contracting for several overseas companies, solely in the arena of medical device clinical trial management. Managing the local sites for a number of diverse studies, Suzanne gained expertise in medical device clinical trials in a diverse range of therapeutic areas including cardiovascular, gynaecology, and reproductive medicine. In 2006, Suzanne joined the clinical team at Ventracor, assisting with the successful completion of the pivotal trials that enabled the company to obtain the CE mark of the device. Suzanne is one of the founding members of Mobius Medical Pty Ltd and her role focuses on liaising with clients and the clinical investigational staff to develop, initiate, resource and project-manage a wide variety of medical device clinical trials. Armed with her thorough understanding of theoretical and practical aspects of GCP, Suzanne also offers advice and conducts training programs for clinical research personnel. |
