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.

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.

Malcolm Dawes

Facilitator of: StyleFlex

Malcolm Dawes is a highly respected and sought after organisational performance consultant with a keen interest in sales and leadership development. In particular he is a recognised expert in helping people understand how to increase their interaction effectiveness when managing people and situations. He has worked both in Australia and in the UK in various training roles within the industry including heading up training for Quintiles & Innovex in Australia/New Zealand. In 2003 Malcolm returned to the UK to set up dta there and established a number of Blue Chip companies as his clients. January 2006 saw Malcolm return to Australia to become Managing Director of dta WORLDWIDE. He has also written on sales leadership for the book ‘Emerging Trends in Professional Selling’ published in June 2011. He has also been a judge for the PRIME Awards for the past 7 years.

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.

Rod Mathews

Facilitator of: The new line manager

Rod Mathews is fast developing a reputation as a leading expert on change and human performance. He has worked with organisations across the commercial and the not-for-profit sectors for over 20 years. His experience, enthusiasm and natural curiosity have allowed him to build an encyclopaedic knowledge of tips, tools and techniques. Rod is a voracious reader of many books and an author of 5.

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.

Lorraine Sutherland, MSc (Medicine), MAppSc (Toxicology)

Facilitator of: Biologicals

Lorraine Sutherland is currently a Senior Manager with Amgen Australia working in regulatory affairs. She has over 17 years of experience in the Pharmaceutical Industry in R&D, as a research scientist), and regulatory affairs (more than 12 years). Lorraine has international regulatory affairs experience in biological therapeutics, in addition to her Australian expertise.  In 2004/05, she acted as the global regulatory lead for a recombinant protein undergoing a manufacturing site change. Lorraine has extensive experience in communicating to small groups, having worked as a tutor and as a demonstrator whilst at university and providing training to staff at Amgen. Lorraine also enjoys coaching junior staff and sharing the knowledge she has gained in her career.

Pat Thomas PhD

Facilitator of: Biologicals

In 2007 Pat was selected to develop the regulatory strategy for the Marketing Authorisation in the EU of a key biological product. As the regulatory lead Pat oversaw the development of briefing documents and participated (presenter for CMC sections) in scientific advice meetings. In this role he provided strategic advice to guide the clinical development strategy post scientific advice meetings. Pat Thomas is currently a Regulatory Affairs Manager with Amgen Australia and has over 12 years of experience in the Pharmaceutical Industry including R&D (protein purification), clinical and drug safety and regulatory affairs. Pat enjoys mentoring junior staff and has extensive experience in communicating to small groups, having demonstrated during university and presented papers at both national and international symposia.

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.