‘Boring Things Are Still Important’* Radiopharmaceutical Regulation

Abstract: The manufacture, supply, transport, use and disposal of radiopharmaceuticals is governed by a broad set of laws and regulations in Australia. With the tremendous global investment and growth in radiopharmaceutical sector, Australian and international regulators are actively reviewing the suitability of existing regulations to radiopharmaceuticals. This seminar will introduce some of the Australia regulations central to the manufacture and supply of radiopharmaceuticals, outline current regulator consultation and highlight that it is everyone in the sector, not just regulatory affairs and QA managers that needs to be familiar with and engaged with existing regulations and their future direction.

[*Chilli Heeler; Bluey Season 1 Episode 22, “The Pool”]

Bio: Dr Nigel Lengkeek is  is the Principal Radiochemist and Cyclotron Manager in the Department of Nuclear and PET at Liverpool Hospital, New South Wales and member of AMTAR scientific advisory committee. Nigel leads a team of radiochemists and engineers delivering routine fluorine-18 radiopharmaceuticals for clinical use, supporting theranostic clinical trials and engaging in research and development with partners from industry and academia.

Nigel is a trained chemist and engineer, having worked in the radiochemistry field for over 14 years on projects covering, radiometal and radiohalogen radiopharmaceutical discovery, radionuclide generator development and theranostic radiopharmaceutical translation, with partners in academia, government and private industry. Nigel has chaired the Radiopharmaceutical Scientists Special Interest Group of the ANZSNM. He is also a past president of the NSW Branch of the RACI.