Learn approaches on how to design your pre-clinical studies from the experts!
This workshop will cover global technical and regulatory strategies for pre-clinical development of medicines, from small molecules and biologics, to cell and gene therapies.
Attendees will attain an in-depth understanding of pre-clinical development pathways and the requirements that will result in the most expedited regulatory strategy.
Case studies will be used to demonstrate the potential pitfalls in the development and registration of drugs and biological medicines, and practical advice will be provided to avoid these as well as illuminate the key elements underpinning successful pre-clinical development.
Workshop Outline:
• CMC issues that impact pre-clinical programs and beyond
• Challenges in pre-clinical development, particularly for complex therapies
• Pharmacology: safety pharm, new developments, animal models and assays
• Toxicology studies and their rational design
• Technical advances in toxicological assessments
• Case studies in the pre-clinical world (successes and failures)
• AU, EU or US – do jurisdictions matter?
• Can there be control of pre-clinical timelines?
Additional Discussion Points:
• Customised approaches to target your product and its intended use
• Optimisation of pre-clinical development
• How to leverage information from regulatory intelligence to maximise outcomes
• Navigation of regulatory challenges across jurisdictions
• Working smarter within the regulatory landscape, especially as a SME
Location: Karstens, 123 Queen Street, Melbourne
Date: Thursday 5th October 2017
Time: Registration 1:45pm, workshop 2:00pm – 5:00pm, followed by networking
REGISTER HERE
In addition to this Melbourne Workshop, ERA Consulting are also offering the workshop in other states: Find out more here
Presenters:
Dr Lesley Earl, Associate Director, ERA Consulting (UK)
Dr Daina Vanags, Associate Director, ERA Consulting (Australia)
Dr Dianne Jackson-Matthews, Chief Scientific Officer, ERA Consulting Group (Australasia)
Dr Lesley Earl – Associate Director at ERA Consulting, UK
Dr Lesley Earl is an Associate Director of Regulatory Affairs for ERA Consulting. She provides expert regulatory and scientific advice with respect to human health to companies seeking development through the regulatory processes in the biopharmaceuticals sector. Lesley is a European Registered Toxicologist, a Fellow of the British Toxicology Society and also a member of the UK In Vitro Toxicology Society. She has over 25 years’ experience in hazard characterisation and risk assessment in the pharmaceutical, agrochemical, chemical and food sectors. Lesley has worked as a senior toxicologist with multi-national companies in the fast-moving pharmaceuticals, foods and consumer goods sectors. She has contributed to the international validation and acceptance of in vitro test methods such as skin and eye irritation/corrosion and phototoxicity and is keen to use appropriate strategies for reducing animal testing. Lesley has a PhD in Toxicology from University College, London and a BSc in Toxicology from the University of Surrey. She has over 25 peer reviewed papers and book chapters and has presented posters and platform presentations at many international and national scientific meetings.
Dr Daina Vanags – Associate Director at ERA Consulting, Australia
Dr Daina Vanags has over 20 years’ experience in scientific research and biopharmaceutical and pharmaceutical development. Daina has a range of skills including executive management in the biotechnology industry, management of pre-clinical and clinical studies, intellectual property, CMC and quality control and bioanalytical assay development (PK, PD and immunogenicity) across various therapeutic areas. At ERA she has worked on a wide range of projects including biosimilar registrations in Australia and the first successful marketing authorisation for a stem cell product in the EU. She has experience with regulatory affairs, pre-clinical and clinical studies in Australia, New Zealand, Central and Eastern Europe and the USA. Daina trained in Pharmacology with a PhD from the University of Adelaide, and postdoctoral positions at Oxford University (Clinical Pharmacology), and the Karolinska Institute (Toxicology and Environmental Medicine). She has published scientific and clinical research studies in a number of key peer-reviewed publications, including The Lancet.
Dianne Jackson-Matthews, BSc, Ph.D, RAC – Chief Scientific Officer and Director of Regulatory Affairs (Australasia), ERA Consulting Group
Dr Jackson-Matthews is Chief Scientific Officer of the ERA Consulting Group, and heads the ERA Consulting (Australia) Pty Ltd operation in Brisbane, Australia. Dianne has over 25 years of experience in pharmaceutical product development, spanning the areas of drugs, biotech/biologics/biosimilars and cell/gene therapies in the US, Europe and Australia. She has experience in development of regulatory and technical strategies, conducts regulatory agency interactions worldwide, prepares regulatory documentation and submissions, and performs regulatory and technical due diligence assessments supporting funding and licensing opportunities for the investment community and the industry.
Prior to joining ERA in 2001 as the Director of the Washington DC office, Dianne was the Director of Regulatory Affairs at a biotech company in New Jersey, where she gained extensive experience with biotechnology products over a 12 year period, covering GMP production, GLP and GCP testing, and regulatory affairs. She also has 6 years’ experience with in vitro diagnostic device development in the US. Dianne has held an Adjunct Associate Professor position at the University of Queensland, Australia, since 2010.
REGISTER HERE
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