Are you a regulatory affairs professional looking to broaden your knowledge and skills base? Ever wanted to know more about biologicals, biological medicines and their registration processes? This two-day online workshop will guide you through the complexities of different classes of biologicals and biological medicines, molecular biology and protein biochemistry concepts, and will allow you to test your knowledge through interactive case studies. With a growing interest in biological medicines among big pharma companies, you will be well placed for the future wave of biotechnological discoveries after attending this workshop.
This training workshop is intended for those who have some experience in Regulatory Affairs (small molecules/NCEs) who are seeking to broaden their knowledge and skills in the development and registration of biologicals and biological medicines.
Get ahead of the game by gaining an understanding of different biologicals and biological medicines, including recombinant proteins, monoclonal antibodies, biosimilars, vaccines and plasma derived products, gene and cell therapies. Unravel the complexities of the multiple registration strategies associated with these products. This workshop is essential for anyone wishing to move into a biotech-based company without prior experience with biologicals or biological medicines.
After attending this workshop, participants should be able to:
Dianne Jackson-Matthews
Dianne is the inaugural Chair of ERA Consulting Group Scientific Advisory Board for the ERA Consulting Group of Companies. With 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. Dianne 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 bioanalytical testing, and regulatory submissions and approvals. She also has 6 years’ experience in the US with in vitro diagnostic device development. Dianne returned to Australia in 2004 to establish ERA Consulting (Australia). She has held an Adjunct Associate Professor position at the University of Queensland since 2010.
Dr Daina Vanags
Senior Director/Principal Consultant, Biopharma Excellence and Head of Development Consulting and Scientific Affairs, PharmaLex
Dr Daina Vanags is Principal Consultant, Senior Director Biopharma Excellence and Head of Development Consulting and Scientific Affairs PharmaLex, previously ERA Consulting. She has over 20 years’ commercial experience spanning scientific research, strategic product development and executive management experience in the biotechnology industry. Regulatory affairs consulting and early phase clinical development with a range of products including drugs, biotherapeutics, biosimilars and cell / gene therapies in the US, Europe, Australia, New Zealand, and India in various therapeutic areas, including rare diseases, including the first successful marketing authorization for a stem cell product in the EU. Expertise in preclinical and clinical bioanalytical assay development (PK, PD biomarker and immunogenicity) with post-doctoral positions at Oxford University UK (Clinical Pharmacology), Karolinska Institute, Sweden (Toxicology) and publications in The Lancet, Hepatology, British Journal of Haematology and others.
Upon completion of this workshop, attendees will receive 14 CPD points
This is an intermediate/advanced workshop. If you have any questions on your suitability for this workshop, do not hesitate to call the ARCS Business Office (02) 8905 0829.
Workshop fees (inc. GST):
Early bird - until 1Nov
ARCS Member - $1315.00
Retired/Student Member - $995.00
Non Member - $2120.00
Standard - from 2 Nov
ARCS Member - $1715.00
Retired/Student Member - $1315.00
Non Member - $2725.00
Please note that virtual workshops at ARCS cover the same content as the physical (face-to-face) workshop. The training material, exercises and student workbook have been redesigned to ensure that the same learning outcomes are achieved as traditional workshops.
The registration fees for virtual workshops have been reduced by $150 per person, per workshop day to reflect the reduction in venue and catering costs associated with a face-to-face workshop (which is reflected in the pricing table above). If you have any questions, please contact us at arcs@arcs.com.au
This workshop runs for two full days from 09:00-17:00
If you're interested in taking this course, please provide your information below, and we'll inform you about the upcoming session's schedule.
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