Eleanor Allan

Facilitator of: Understanding the GCP Audit Process

Following graduation from Aberdeen University with an honours degree in Microbiology, Eleanor commenced work in the pharmaceutical industry and has worked in pharmaceutical research for 23 years. For the past 12 years she has specialised in clinical research training and auditing and in October of 2000 she set up her own clinical research training and quality assurance auditing company, Caledonian Clinical Training. Since then, she has trained and worked with diverse groups including pharmaceutical company sponsors, biotechnology companies, research nurses, investigators, academic research groups and ethics committees both in Asia and Australia.

Joseph Badolato PhD, ACPM

Facilitator of: Overview of Drug Development & Conducting Clinical Research - Essential GCP Training for Study Coordinators

Joseph Badolato, PhD, is currently the Professional Development Manager with ARCS Australia. He has a PhD in the field of Endocrinology (molecular biology) and has been working in a variety of roles within the pharmaceutical industry including within clinical research, quality and training for about 10 years. In his current role he is responsible for working closely with the ARCS Interest Area Committees and the ARCS Board to deliver quality educational events.

Jan Burnes

Facilitator of: People Skills Courses

Jan Burnes is a dynamic Trainer and Corporate Facilitator with over 25 years experience in the area of Leadership and Management. Previously the managing director of a top performing company employing over 1,000 people, Jan now uses her real-life experience in developing people at all levels to achieve higher standards of performance and productivity.

Jan is now the Managing Director of “Business in Action”, a highly successful consultancy providing tailored learning solutions for many of the top one hundred industries in Australia. She believes that effective learning has to be participative and interactive – her learning events are built around practical exercises, role play and real life case studies. Her training style focuses not only on explaining new ideas or developing new skills, but also on motivating people to use them and develop themselves as individuals.

Vicky Clarke

Facilitator of: Business Writing Skills & Advanced Business Writing Skills

Vicky majored in English Literature at the University of Sydney and subsequently trained as an ESL (English as a Second Language) teacher. She has taught overseas students at the University of Technology in Sydney and has also coached students in English and History at HSC Level. For over 10 years, Vicky has taught professional writing skills to participants across a range of business sectors, both locally and interstate. Her professional career spans the finance, manufacturing and pharmaceutical research industries, and she trains regularly for ARCS (the Association of Regulatory & Clinical Scientists) in Sydney and Melbourne.

Helen Critchley

Facilitator of: Regulation of Pharmaceuticals in the European Union

Dr. Helen Critchley MRPharmS, PhD, graduated as a pharmacist from the University of Bath in the UK and undertook PhD at the University of Nottingham specialising in industrial pharmacy. Helen has spent over 20 years in the pharmaceutical industry with her initial career working for a number of major pharma companies in formulation development and acting as the quality expert for EU regulatory submissions before transferring to a full time regulatory position.

Helen has worked in various EU headquarter offices of small, medium and large pharma companies and as a consultant responsible for global drug development and regulatory submissions across a broad range of therapeutic areas. Particular specialisation in registration of biotech products through the EU centralised procedure, and registration of the first ever orphan drug in the EU. Helen is currently Director of Regulatory Affairs ANZ and member of the Executive Leadership Team for Abbott Australasia Pty Ltd based in Botany in Sydney.

Sarah Culhane

Facilitator of: CRA2 - Managing Your Trial Sites More Effectively

Sarah is an independent clinical research consultant working with pharmaceutical and biotech companies either currently running trials in Australia and New Zealand or looking at doing so in the future.

Theresa Dickson-Bogie

Facilitator of: Introduction to Australian Regulatory Affairs

Theresa Dickson-Bogie has over 16 years of professional experience in Regulatory Affairs in both Pharmaceutical and Agricultural industry working with a broad range of products (incl. NCE, biotech entities, generic drugs, pesticides, insecticides and veterinary products).  Theresa has managed and directed regulatory projects for Australia and New Zealand in multiple therapeutic areas including oncology, CNS/neurology, growth hormone, infertility (hormones), immunology (antibodies), over-the-counter medicines, complimentary medicines and medical devices.  In addition, she also has 12 years experience in Quality System Creation, implementation and maintenance.

For the past 2 years Theresa has been working as an independent consultant to the pharmaceutical industry.

Tracey Edinburg

Facilitator of: CRA1 - Essential GCP Training for New CRAs

Tracey Edinburg holds a Masters Degree in Pharmacy from the University of Pretoria in South Africa as well as a Bachelor of Arts Degree from the University of South Africa with Majors in French Literature and Philosophy. She has over 20 years™ experience in multinational and local pharmaceutical sponsored clinical research in drug and devices across a broad range of therapeutic areas and all phases of research. Tracey specialises in all activities relating to setting up and monitoring clinical trials from protocol design to study close out. Tracey is a lecturer for the Masters in Drug Development course at UNSW and has conducts CRA1 training for ARCS as well as in Asia.

Mike Flood BE, FIEAust, CPEng (Biomedical)

Facilitator of: Medical Devices 101

Michael began his career in medical devices in the late seventies with qualifications in Engineering. Through his career he has seen all sides of the medical devices industry, commencing with a number of years in technical management and marketing for an Australian manufacturer, nearly ten years with a State Health Department Biomedical Engineerring Unit.

In 1993 he joined the national regulatory agency, the Therapeutic Goods Administration, where he re-established the agencies post-market programs for medical devices, following the recent establishment of the organization from a number of separate groups within the Commonwealth Health Department. He has also had extensive involvement with premarket assessment systems management, and was one of the senior management team responsible for introduction of a GHTF based regulatory framework for medical devices in 2002. Of more recent times he has had involvement in policy development related to regulatory reform based on the TGA experience with the GHTF framework over the last eight years.

Having left the TGA in mid 2010, he has established a consultancy practice in Australia - Locus Consulting, specialising in regulatory affairs, international regulatory training for economies introducing devices regulations, health technology assessment and biomedical engineering.

Dianne E. Jackson-Matthews, BSc (Hons) Phd, RAC

Facilitator of: Regulation of Pharmaceuticals in the USA

Dr. Jackson-Matthews is Deputy Group Director of Regulatory Affairs for the ERA Consulting Group, and Director of ERA Consulting (Australia) Pty Ltd in Brisbane. Other ERA locations are in London, Germany and Washington DC. Dianne has 18 years experience in regulatory strategy development and regulatory submissions spanning the areas of drugs, biotech/biologics and cell-based products. Prior to joining ERA in 2001 as the Director of the Washington office, Dianne was the Director of Regulatory Affairs at Unigene Laboratories, Inc., a biotechnology company in New Jersey, USA, where she gained extensive development experience over a 10 year period in the production and bioanalytical testing of biotechnology products. Dianne has experience in regulatory and technical strategy, agency interactions and pre- and post-marketing submission work. In addition, she also has 6 years experience with in vitro diagnostic devices in the USA. As Director of the Australia office Dianne is responsible for Australian, European and US client programs, offering international perspective to strategic and technical product development in those regions.

PM- Partners group

Facilitator of: Project Management For Therapeutic Development & An Introduction to Project Management for the Therapeutics Industry

PM-Partners group is Australia's most highly certified project management specialist. They are PMI Global Registered Education Providers, a PRINCE2 ATO, a MSP ATO, Registered AIPM Assessors, recognised as a Project Managed Organisation by the Australian Institute Of Project Management, endorsed course provider for the International Institute for Business Analysis, a Government Endorsed Supplier and a formal RTO Partner with ETAS Pty Ltd (RTO #1967), enabling AQTF qualification award to Certificate IV, Diploma & Advanced Diploma in Project Management.

Karen Raines

Facilitator of: Medical Affairs 101

Karen began her pharmacy career in retail and hospital pharmacy and then moved into the pharmaceutical industry where she has worked for the last 10 years specializing in Medical Affairs and Medical Information. Through her experience at various pharmaceutical companies including Bristol-Myers Squibb, Astrazeneca and Pfizer she has developed her medical affairs skills in promotional review, sales force training, and worked in the medical affairs capacity in the many stages of the drug development lifecycle. Currently Karen is completing a Certificate IV in Training and Assessment and consulting as a trainer as well as developing education programs within the pharmaceutical industry.

Teresa Schafer

Facilitator of: Protecting your Legal Rights; Section 6.6 of the MA Code of Conduct

Dr Teresa Schafer is a partner in Piper Alderman's Corporate Group. She is both a lawyer and scientist, and has extensive experience in the regulation of therapeutic goods in Australia and New Zealand. She provides broad advice to clients in the pharmaceutical and medical device industry on regulatory and reimbursement issues; generic defence strategy; patent protection and infringement; clinical research issues; promotion and advertising; and product safety and recalls. In addition to her role at Piper Alderman, Teresa is a part-time member of the Administrative Appeals Tribunal, and hears matters in the General and Veterans Appeals Divisions, which includes reviewing decisions of the TGA.

Dominic Tilden

Facilitator of: TreeAge Training

Dominic Tilden has been teaching the TreeAge course in Australia, New Zealand and the UK for over five years. Dominic is the director of THEMA Consulting Pty Ltd and has worked in health economics and health economic modelling for over 10 years. He has managed and implemented health economic modelling projects using 1st and 2nd order Monte Carlo simulation, discrete event simulation, Markov and semi-Markov models, decision analytic models, trial based economic evaluations and probabilistic sensitivity analysis. In latter years, Dominic has been project manager for a large number of health economic evaluation and reimbursement application projects on behalf of clients in Australia (PBAC), the UK (NICE and SMC) and Europe. Dominic started THEMA Consulting in 2006.

Susan Walters

Facilitator of: Applying Bioavailability and Bioequivalence (BABE) Guidelines

Dr Susan Walters is well known in the pharmaceutical industry as a former TGA employee who, for 25 years, was responsible for the section that evaluated premarket chemistry, quality control and bioavailability data for prescription medicines. She qualified as a pharmacist in the UK and proceeded to a PhD at the University of Strathclyde (Scotland) entitled The chemistry and biological activity of some new 6,7-benzomorphans. Migrating to Australia in 1971, she first worked in the pharmaceutical manufacturing industry specialising in quality control and pharmaceutical development, then joining the National Biological Standards Laboratory which later became part of the Therapeutic Goods Administration.

Dr Walters currently works as a pharmaceutical consultant and teacher. She has adjunct appointments as Associate Professor with the Universities of NSW and Canberra, and is a member of three WHO committees. Since leaving TGA in 2001, she has undertaken numerous consultancies for WHO and other international organisations, including the World Bank (via the Australian Health Insurance Commission), the EC-ASEAN Economic Cooperation Program and the Global Fund to treat AIDS, TB and Malaria. Projects have included review of the management and conduct of drug regulatory authorities in six countries. She has a particular interest in projects that marry legislation with science, and regularly provides advice to lawyers acting on behalf of pharmaceutical companies in Australia and overseas.