July 2, 2008
ihbi Building, Kelvin Grove Campus, QUT, Brisbane Queensland
Abstracts
Andy de Jager, Manager - Analytical Development, Q-Pharm, Pty Limited
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The FDA Compliant Validation In order to accept clinical study data, the FDA, along with other regulators, demand the use of assays that have endured the rigours of appropriate validation testing. While the assessment of assay performance (accuracy, precision, recovery, extract stability) represents a well-understood battery of tests, in recent times, regulators are paying closer attention to issues around sample viability. There is a call from some quarters to perform selected validation studies on real samples, and there is some debate regarding the applicability of stability data generated using quality controls. There are now a number of proponents advocating the use of clinically incurred samples to revisit selected validation studies, and indeed, there is growing support for a subset of mandatory re-assays in support of clinical data. The aim of this presentation is to flesh out issues relating to demonstration of sample viability, within the context of affordable quality. The ever increasing demands on method validation means that validation studies should be well designed to generate maximum data from a relatively small collection of samples, in order to remain financially competitive. |
Brian Creese, Consultant in Preclinical Drug Development, Brian Creese Consulting
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Preclinical Safety Studies of Experimental Medicine Prior to the administration of an experimental medicine to human subjects in a clinical trial, a battery of preclinical studies must be completed in vitro and in animals to provide information about the potential safety risks. This information must be provided to the local regulatory agency and/or the human research ethics committee before the clinical trial can commence. The extent of preclinical safety testing is described by the International Conference on Harmonisation (ICH), and is dependent on the duration of the proposed human exposure, the stage of clinical development and the target patient population. First-in-human trials usually require information on safety pharmacology, pharmacokinetics, toxicokinetics, local tolerability, acute toxicity, short-term repeated dose toxicity and in vitro genetic toxicity. The preclinical safety studies must be conducted in compliance with Good Laboratory Practice (GLP). Go to Speakers or. Go to Program |
Gilmore, Rowan, Chief Executive Officer, Australian Institute for Commercialisation
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Overview on New Product Development New product development is critical to the success, survival, growth and renewal of organisations. New products provide a steady stream of cash flow for business as a result of satisfying customer needs and wants. Organizations must also cater for the changing needs and wants of customers; otherwise competitors will try to fulfil these needs. New products provide a potential source of competitive advantage and allow organisations to diversify, adapt and even re-engineer to match evolving markets and changing environmental conditions. The presentation will provide an overview of new product development and the successful commercialisation of products that is a critical component of an organisation's innovation strategy. Go to Speakers or. Go to Program |
Mario Pennisi, Chairman, Australian Organisation for Quality Queensland Inc, and Managing Director, World Conference Systems
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The AOQ/Progressing Business Institute What is the AOQ? What is teh Progressing Busienss institute? |
Plum, Ted, Operations Manager, Alkaloids of Australia Pty Ltd
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Active Pharmaceutical Ingredients (API's) in Australia - A Manufacturer's View
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Smith, James, Senior Lecturer, Queensland University of Technology, Faculty of Science, School of Life Sciences
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Quality Systems Education within University Science Increasing emphasis on quality management in industries employing university science graduates necessitates integration of quality systems education into science curricula. This includes undergraduate, honours and postgraduate curricula. In the Australian academic system, the latter two focus almost exclusively on research, and comprise the numerical minority of overall university leavers. However, all graduates are likely to interact with quality systems during their career, hence effective general knowledge of such systems is desirable. Few academic programmes offer quality systems-based education except where such education forms a required component of accredited programs (pharmacy, food technology, food safety, etc). Hence, a large proportion of current practical quality systems education either occurs on-the-job, or via external quality training coursework and/or certification programmes. Many students misperceive quality systems (and hence employment) as "box-ticking." Additionally, the myriad real-world, often discipline-specific, regulatory and certification bodies can be daunting. In order to provide university graduates capability to "hit the ground running" regarding scope and utility of quality systems to utilisation of experienced, external quality systems guest lecturers and contextual placement of quality systems is recommended. Suggestions and challenges regarding bioanalytical and environmental quality systems content within selected university science curricula are presented. Go to Speakers or. Go to Program |
Styzinski, John, Deputy Technical Manager, NATA
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NATA R&D Accreditation Laboratory Accreditation and associated programs cover a broad range of technical disciplines and serve a large number of industry and public benefit sectors. NATA's newest accreditation program recognises the technical and research management competence of research and development facilities using the international standard ISO/IEC 17025. There are two accreditations in the R&D Program at present with further interest from a number of facilities. The early interest in the program has been from the biotechnology and pharmaceutical industries, however, the potential longer term reach of the program is broader than this. In research and development and the regulated research sector in particular, two other NATA programs also operate in defined areas of the research environment. These are the Medical Testing (pathology) program for tests of a "routine" nature that might be performed as part of clinical trials and NATA's Good Laboratory Practice Compliance Monitoring Program for the conduct of non-clinical health and environmental safety studies of test items contained in various chemical products. An overview of the R&D Program will be presented covering the interface it has with existing NATA programs. Go to Speakers or. Go to Program |
Paul Taylor, Senior Chemist, Department of Clinical Pharmacology, Princess Alexandra Hospital
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The Fitness of Purpose of Analytical Methods If the results of an analytical method cannot be trusted then it has little value and the test might as well be not performed. When analytical work is commissioned by a customer it is assumed the laboratory has a degree of expert knowledge and will provide the right answer to the analytical problem at hand. Thus analytical measurements should be made using methods and equipment which have been tested to ensure they are fit for purpose. The correct method validation enables analytical chemists to demonstrate that a method is fit for purpose. The aim of this presentation is to provide an overview of issues related to method validation by discussing what is involved, why it is important and how it can be achieved. Go to Speakers or. Go to Program |
Heather Worthey, Quality Assurance Manager, Health World Ltd
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GMP in Complimentary Manufacture |
Co-Hosts
The Regulated Research & Development and Manufacturing Division, AOQ-QLD
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Institute of Health and Biomedical Innovation, QUT
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