Select Publications
Book Chapters
, 2025, 'How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth in the Artificial Intelligence Era', in Medical Regulatory Affairs an International Handbook for Medical Devices and Healthcare Products Fourth Edition, pp. 1 - 7, http://dx.doi.org/10.1201/9781003611264-1
, 2025, 'The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals', in Medical Regulatory Affairs an International Handbook for Medical Devices and Healthcare Products Fourth Edition, pp. 11 - 20, http://dx.doi.org/10.1201/9781003611264-3
, 2023, 'Regulatory Landscape in Australia and New Zealand', in Handbook of Cell and Gene Therapy from Proof of Concept Through Manufacturing to Commercialization, pp. 233 - 242, http://dx.doi.org/10.1201/9781003285069-15
, 2023, 'Training Approaches to Build Cell and Gene Therapy Workforce Capacity', in Handbook of Cell and Gene Therapy from Proof of Concept Through Manufacturing to Commercialization, pp. 175 - 182, http://dx.doi.org/10.1201/9781003285069-10
, 2021, 'Authorization Procedures for Pharmaceutical Products', in Hall G (ed.), Fundamentals of International Regulatory Affairs, Regulatory Affairs Professionals Society, USA, pp. 187 - 206, https://my.raps.org/online-store/merchandise-details/?id=0eeaf613-5fd3-eb11-ba5e-0003ff45124f&reload=timezone
, 2018, 'Authorization Procedures for Pharmaceutical Products', in Jones P (ed.), Fundamentals of International Regulatory Affairs, Regulatory Affairs Professional Society, USA, pp. 91 - 108
, 2017, 'Authorisation procedures for pharmaceutical products', in Jones P (ed.), Fundamentals of international regulatory affairs, RAPS, MD, USA, pp. 69 - 80, https://www.raps.org/ProductDetail.aspx?ProductId=131091030