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In Vitro Diagnostics Regulation (IVDR)
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Robert has more than 25 years’ experience in the Australian and New Zealand pharmaceutical industry. Robert’s career extends to managing multi-national corporate teams in Regulatory Affairs, Quality Assurance, Product Development, Clinical Research and Strategic Planning & Business Development. Roberts career highlights include achieving the world-first regulated market approval of a biosimilar.
TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches.
Jean has proven experience in all phases of the product lifecycle, driving compliance from concept initiation through to commercialisation and post-market support. He provides Regulatory and Quality Assurance expertise to a broad range of companies and supports projects involving various medical technologies. He is bilingual in French and English and holds a Masters’ Degree of Engineering.
Piety has worked in the Australian and New Zealand Pharmaceutical Industry for over 20 years. Piety is a skilled Regulatory Affairs professional, and an experienced people manager having managed Regulatory affairs teams both locally and internationally within large pharmaceutical companies.
Doug Kentwell has more than 30 years direct senior experience in the Australian federal health and welfare sectors. He is widely acknowledged and respected as a leading authority on Australian machinery of government, especially therapeutic product regulation, having played a key role in the development and implementation of the Therapeutic Goods Act 1989.
Doug takes the lead on all Australian regulatory appeal activities and has a strong success rate in positive appeal outcomes of over 80%.
Daina has 16 years’ experience in pharmaceutical product development (proteins, antibodies, biosimilars, vaccines, cell-based products), including biotechnology executive experience (Australia, USA). Daina trained in pharmacology with a first-class honours and PhD (University of Adelaide), post-doctoral positions in clinical pharmacology (Oxford University, UK) and toxicology (Karolinska Institute, SE).