This content is current only at the time of printing. This document was printed on 8 September 2020. A current copy is located at http://www.gitygostar.com/node/18421
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Program and speaker information—Canberra industry information and education session 15 and 16 October 2015
Day one (Thursday 15 October)—New approaches to risk assessment
|9–9.15 am||Welcome from Kareena Arthy|
|11.30 am – 1?pm||
Dietary exposure methodologies session
|3.30–3.45?pm||Afternoon tea (grab and go)|
|4.55–5?pm||Closing remarks from Kareena Arthy|
Day two (Friday 16 October)—Information and education session
|8–9 am||Registration– Lower Ground Floor|
|9–9.15 am||Welcome and Setting the Scene (Kareena Arthy)|
|9.15–10.30?am||Registration Update, including changes to pre-application assistance?|
|10.30–10.45 am||Morning tea|
APVMA’s Risk Profiling Tool update
|11.30am–12.00 pm||Establishing product equivalence and CCI|
|12–12.20 pm||Chemical review update|
|12.20–12.40 pm||Compliance update|
|12.40-1 pm||Online service update|
|1–2?pm||Lunch and networking—day ends|
More information about the speakers from day one
Distinguished Professor Jim Riviere
Dr. Jim E. Riviere is the MacDonald Endowed Chair, Kansas Bioscience Eminent Scholar and a University Distinguished Professor at Kansas State University in Manhattan where he is the founding director of the Institute of Computational Comparative Medicine.
He spent the first three decades of his career at North Carolina State University in Raleigh as a Burroughs Wellcome Fund Distinguished Professor in Pharmacology. He received his BS (summa cum laude) and MS degrees from Boston College, his DVM and PhD in pharmacology as well as a DSc (hon) from Purdue University. He is an elected member of the National Academy of Medicine, and serves on the National Research Council (NRC) Board of Agriculture and Natural Resources.
He previously served on the Board of Scientific Counselors of the NIEHS National Toxicology Program, the FDA Science Advisory Board as well as on numerous NIH Study Sections, FDA Committees and journal editorial boards. He is the Editor of the Journal of Veterinary Pharmacology and Therapeutics and confounder of the USDA-supported Food Animal Residue Avoidance and Depletion (FARAD) program. His honors include the 1999 O. Max Gardner Award from the Consolidated University of North Carolina, the 1991 Ebert Prize from the American Pharmaceutical Association, the Harvey W. Wiley Medal and FDA Commissioner’s Special Citation, and the Lifetime Achievement Awards from both the European and American Association of Veterinary Pharmacology.
Dr. Riviere has been PI on over 20 million dollars of extramural grants and published 550 full-length research papers and chapters, holds 6 U.S. Patents, and has authored/edited 11 books in pharmacokinetics, toxicology and food safety. His current research interests relate to the development of animal models; applying biomathematics to problems in toxicology, including the risk assessment of chemical mixtures, pharmacokinetics, nanomaterials, absorption of drugs and chemicals across skin; and the food safety and pharmacokinetics of tissue residues in food producing animals. Jim has been married to fellow toxicologist Dr. Nancy Monteiro-Riviere for 39 years and have three adult children.
Dr Phil Reeves
Dr Phil Reeves has been appointed to the new role of APVMA Chief Scientist.
The APVMA’s Chief Scientist will ensure our regulatory science frameworks and standards continue to meet appropriate national and international standards.
Through engagement with national and international scientific and regulatory networks, the Chief Scientist will identify issues and trends that may impact on the integrity of our regulatory science frameworks and standards and develop appropriate projects and initiatives to enhance our scientific capability.
The role will also provide the Chief Executive Officer and senior staff direct access to independent, expert advice on regulatory decisions and scientific aspects of the APVMA’s regulatory framework, and will manage the APVMA’s Principal Scientists and special projects.
Dr Reeves holds a Bachelor of Veterinary Science (Honours) degree from the University of Queensland and a PhD in pharmacology from the University of Western Australia. He is a Fellow of the Australian and New Zealand College of Veterinary Scientists in veterinary industrial pharmacology and is a registered specialist in veterinary pharmacology.
He comes to this role with both private and public sector experience with his early years as a practicing vet, then later in molecular pharmacology and toxicology research. Since joining the APVMA in 1992, he has held senior positions, most recently as Principal Scientist and Chief Regulatory Scientist Veterinary Medicines.
Dr Reeves has represented Australia at major international forums, including OECD, FAO/WHO and VICH working groups. He has presented more than 100 invited lectures in Australia and overseas and he has published numerous scientific journal articles and book chapters.
Ms Janis Baines
Janis Baines holds a Master in Human Nutrition and has worked in food regulation for over 20 years; she is currently the Manager of the Food Data Analysis Section at Food Standards Australia New Zealand (FSANZ).
Her section provides dietary exposure estimates for food chemicals including agvet chemicals that are based on national nutrition survey data for Australian and New Zealand populations. These data are critical in the FSANZ risk assessment process and standard development and are also used by APVMA to establish MRLs. Janis has been a member of JECFA since 1996 as a dietary exposure assessment expert and attended CCPR on a number of occasions as part of the Australian delegation, Janis was involved in several FAO/WHO expert groups on dietary exposure, such as the 1997 meeting that developed the short term exposure equation (IESTI) for international assessments and a follow up workshop in 2005 that refined the equation. In 2011 Janis chaired an expert meeting that investigated new dietary exposure assessment approaches for international veterinary drug residue assessments, held in conjunction with the JECFA Veterinary Drugs meeting.
Janis was seconded to the Department of Health from late 2009 to mid-2011 to work with the Australian Bureau of Statistics (ABS) and a wide range of experts to develop and implement the 2011-13 Australian Health Survey, which is the most recent source of information on what Australians are eating. She is still involved in working with the ABS and Health on other related projects, such as reporting data from the survey against Australian Dietary Guidelines.
Dr Jason Lutze
Jason Lutze comes from a mixed farming background in South Australia, which has given him an appreciation of the importance of maintaining productivity and profitability in agriculture. This experience led him to undertake a Rural Science degree at UNE, majoring in agronomy. He then accepted an opportunity to undertake research into grassland productivity via a PhD program at CSIRO and ANU. From there he progressed to government and work on agvet chemicals and their residues.
Jason is now the Director, Residues and Trade, at the Australian Pesticides and Veterinary Medicines Authority (APVMA) where he leads the team responsible for evaluation of the residues and trade aspects for new uses of pesticides and veterinary medicines in Australia, including those for use under permit. This includes the safety assessment of residues, Maximum Residue Limit (MRL) determination and establishment, determination of withholding periods and of residues and trade related label instructions.
Jason has more than 15 years’ experience in areas related to residues, including MRL establishment at the APVMA, management of residues testing programs with the National Residue Survey, and in export market access with (the then) AQIS. He is a member of the Australian delegation to the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), and is actively involved in preparing Australian delegation briefs for CCPR. Jason is a member of the OECD Residue Chemistry Expert Group and is co-chair of a writing group developing guidance for conduct of rotational crop field trials.
Distinguished Professor Nancy Monteiro-Riviere
Dr. Nancy A. Monteiro-Riviere, is a Regents Distinguished Research Scholar and University Distinguished Professor of Toxicology and Director, of the Nanotechnology Innovation Center of Kansas State (NICKS). She was a Professor of Investigative Dermatology and Toxicology at the Center for Chemical Toxicology Research and Pharmacokinetics, North Carolina State University (NCSU) for 28 years. She is also a Professor in the Joint Department of Biomedical Engineering at UNC-Chapel Hill/NCSU and Research Adjunct Professor of Dermatology, at UNC-Chapel Hill School of Medicine.
She has a B.S. (cum laude) in Biology from Stonehill College, North Easton, MA and M.S. and Ph.D. in Anatomy and Cell Biology from Purdue University, West Lafayette, IN and completed a postdoctoral fellowship in toxicology at Chemical Industry Institute of Toxicology in Research Triangle Park, NC.
She was past-President of both the Dermal Toxicology and In Vitro Toxicology Specialty Sections of the National Society of Toxicology. Dr. Monteiro-Riviere is a Fellow in The Academy of Toxicological Sciences and was elected to the Board of Directors, and in the American College of Toxicology.
She was the recipient of the Purdue University inaugural Distinguished Women Scholars Award, Kansas State University Woman of Distinction, and elected to attend the National Academy of Sciences special Keck Futures Initiative Conference on “Designing Nanostructures at the Interface Between Biomedical and Physical Systems”.
She serves as Associate Editor for Wires Nanomedicine and Nanobiotechnology and for Materials Science and Engineering C: Materials for Biological Applications; and serves on the Editorial Boards of Nanomedicine, Nanotoxicology, Journal of Applied Toxicology, Cutaneous and Ocular Toxicology, Research and Reports in Transdermal Drug Delivery, and Toxicology in Vitro.
She has served on several national and international expert review panels, including many in nanotoxicology, such as the National Research Council of the National Academies to Review the Federal Strategy to Address Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials and the International Council on Nanotechnology.
She has served as an invited expert for the National Nanotechnology Initiative on Nanomaterials, ILSI Europe Task Force-Expert Group-COSMOS, and the European Commission Health and Consumers Directorate SANCO-Scientific Committee on Consumer Safety. She was selected by Thomson Reuters’s 2014 highly cited researchers list ranking among the top 1% most highly cited researchers in pharmacology and toxicology.
She has given more than 147 invited presentations and published over 300 manuscripts in the field of skin toxicology and nanotoxicology and is Editor of the books “Nanotoxicology Characterization and Dosing and Health Effects” and “Toxicology of the Skin - Target Organ Series” and “Nanotoxicology: Progress toward Nanomedicine”. Her current research interests involve in vivo and in vitro studies of skin absorption, penetration and toxicity of chemicals, nanoparticles, development of novel scaffolds for tissue engineering and novel pharmaceutical drug delivery devices.
Professor Michael Roberts, Universities of South Australia & Queensland
Professor Roberts is a NHMRC Senior Principal Research Fellow, Professor of Therapeutics & Pharmaceutical Science at the University of South Australia and Professor of Clinical Pharmacology & Therapeutics at The University of Queensland with 40 years research experience. He established and is Director of the Therapeutics Research Centre (TRC), based at the Princess Alexandra Hospital (Brisbane) and The Queen Elizabeth Hospital (Adelaide).
He has been awarded both ASCEPT’s RAND and APSA’s medals, is a former APSA President, a Fellow of the Australian College of Pharmacy, a APVMA Fellow in Nanoscience and a Fellow of the Australian Academy of Health and Medical Science
Mark Jenner, Scitox Assessment Services, Canberra
Mark Jenner graduated with a BSc (Hons, majoring in zoology) at the University of Adelaide in 1982. For the next nine years, he worked at the Flinders Medical Centre and the Repatriation General Hospital, Daw Park as a research assistant on projects studying the metabolism and organ toxicity of volatile anaesthetics and solvents and the anti-arthritis drug, methotrexate. After obtaining his MSc from the Flinders University of South Australia, he made the transition from workbench to workstation – and the move from Adelaide to Canberra – to become a toxicology evaluator in the Department of Health.?
Between 1991 and 2006, he was involved in the public health assessment of new and existing pesticides, veterinary medicines and industrial chemicals; participated in the development of Australian government policy on the regulation and use of chemicals; liaised on chemical regulatory issues with Australian and overseas government departments, the APVMA, NOHSC, FSANZ and the chemical manufacturing industry; provided advice to the OGTR on the public health implications of genetically modified organisms; was the principal author of the OECD Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity studies; and was an adviser to the WHO on the development of the IPCS conceptual framework for evaluating modes of action for chemical carcinogens.
In March 2006, Mark established Scitox Assessment Services and became a consultant specialising in scientific writing and reporting on toxicological issues related to public and occupational health. His projects have included evaluations of pesticides, food contaminants, and human and veterinary drugs for the APVMA, TGA and FSANZ; reviews of computerised models for estimating human exposure to pesticides during and after application; assessments of exposure and risk to council employees during weed spraying activities; authorship of an APVMA web publication on the herbicide glyphosate (at http://archive.www.gitygostar.com/news_media/docs/glyphosate_scitox_review_july_2013.pdf); and co-authorship of Mueller U, Bartholomaeus A & Jenner MA (2008) Dermal absorption of chemicals: Some Australian regulatory considerations. In Dermal Absorption and Toxicity Assessment - 2nd Ed; Roberts MS and Walters KA, Eds., pp 459-470 (Drugs and the Pharmaceutical Sciences, Vol 177).
Andrew Negri, Australian Institute of Marine Science
After his PhD in 1993, Andrew spent 10 years studying natural cyanobacterial toxins in marine and freshwater ecosystems at AIMS and CSIRO.
He has been at AIMS for the last 20 years and in the late 1990s, his research became more coral reef-focussed, including studies coral spawning
During the 2000s he focussed on identifying the toxic thresholds of pollutants on a range of marine species, including corals, sponges, algae and seagrass from Antarctica to the GBR.
Current research concentrates on understanding the combined effects of pollution and climate change on tropical marine organisms.
Pollutants of interest include pesticides, metals, POPs, petroleum products and sediments from dredging.
Chris is the director of Australian Environment Agency Pty Ltd. For 20 years he has been involved in the agricultural/veterinary and industrial regulatory industry in Australia, primarily in the field of environmental risk assessment.?
Chris worked for eight years with the Department of the Environment (DotE) undertaking the environmental risk assessments for agricultural, veterinary and industrial chemicals submitted to the relevant regulators for registration/approval. For several years he managed the Chemical Assessment Section within DotE and provided input to NICNAS and the APVMA on environmental technical and policy issues.
Since leaving the Department, Chris has been working as a consultant in this field, primarily undertaking the Governments environmental assessments for the APVMA on a sub-contracting basis, and assisting industry with their regulatory submissions for the APVMA.
Chris has been actively involved in a technical capacity on several national and international programs relating to environmental risk assessment of chemicals.
Janine Glaser, APVMA
Janine Glaser is from Ontario, Canada where she pursued a BSc in environmental toxicology and an MSc in zoology/toxicology at the University of Guelph. Upon graduation, she spent two years as an environmental risk analyst at CanTox Environmental (now Intrinsik Inc), followed by 12 years at Health Canada’s Pest Management Regulatory Agency (PMRA). Janine had diverse roles and experiences at the PMRA, including Senior Scientific Evaluation Officer in environmental assessment, Science Team Lead in registration activities, and a six-month work exchange at USEPA’s Environmental Fate and Effects Division.
Coupled with extensive experience working as a global lead in various joint review projects, Janine has developed strong ties with regulatory & environmental experts around the world, which has led her to join the Australian Pesticides and Veterinary Medicines Authority (APVMA) in 2012 as a Senior Evaluator. Janine is now the Environmental Assessment Coordinator at the APVMA where she provides advice in relation to aspects of environmental assessments and manages relationships with the Department of the Environment and other external service providers. Janine has more than 16 years’ experience in areas related to environmental risk assessment, and is a member of the Society of Environmental Toxicology and Chemistry?(SETAC).
Dr Chris Schyvens, APVMA
Chris is the Health Assessment Coordinator at the APVMA–leading a team of toxicologists providing toxicological and safety advice supporting registration program. Participating in the WHO/FAO Joint Expert Committee on Food Additives (Veterinary Medicines) 2015. Bachelor of Science degree from Sydney University majoring in microbiology and pharmacology. PhD from the University of NSW in cardiovascular pharmacology and physiology.
Previously, researcher at the John Curtin School of Medical Research (ANU), senior toxicologist at the TGA and senior toxicologist/risk manager at FSANZ. Over ten years’ experience in toxicology and risk assessment of chemicals in human therapeutics, food, agriculture and veterinary medicines.