M.Sc. MAICD With more than 25 years of global health and medical research translation and commercialisation experience, Anita knows what it takes to move science from bench to business. Anita is an influential life sciences leader with extensive experience across industry, government and academia. Driven by strategic partnerships that realise value, Anita has delivered multiple portfolios in excess of $100M. She is founder and director of boutique consultancy, Innoveren - partnering to deliver innovation, translation and commercialisation for the life sciences sector. She is an experienced non-executive director and advisor including peak organisations such ARCS, AusBiotech, Australian Clinical Trial Alliance and BioNSW, where she helps grow and influence the Australian life sciences sector. She has previously held leadership positions with Australia’s national science agency CSIRO, Office for Health and Medical Research in NSW Government, as well as multinational pharmaceutical and medtech companies including Medtronic and Merk & Co. Anita holds post-graduate qualifications in science, as well as competitive strategy and innovation from the London School of Economics . She is based in Sydney, Australia.

Ivy has worked in Quality and Regulatory Affairs in the Australian and New Zealand medical devices and diagnostics, pharmaceutical, complementary medicine, and food industries for nearly 20 years. From major multinationals to small start-ups, Ivy has experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and global product launches. Ivy has extensive knowledge and practical Quality and Regulatory Affairs experience gained through various roles including a Senior Quality and Regulatory Affairs member at an Australian diagnostics manufacturer, Regional Regulatory Affairs Manager Asia Pacific with a US pharmaceutical/medical devices manufacturer and Regulatory Affairs Engineer at a New Zealand medical devices manufacturer. Ivy has successfully delivered regulatory approvals including US FDA 510(k), Health Canada, CE marking, TGA, Medsafe, and PMDA; she has provided due diligence activities for company acquisitions regarding the target’s regulatory position. Ivy holds a Master of Science and is a certified Quality Management System lead auditor for ISO 13485:2016 which enables her to support businesses with their quality system requirements.

Hamish King, LLB, RAC is CEO at Cisema, a regulatory and compliance consultancy for China founded in Munich and Beijing in 2002. Cisema is a 100-strong family-owned company providing regulatory and compliance services for China and Hong Kong, including product registration, in-China testing, clinical studies and writing, regulatory communications, local agent, post market surveillance, quality control and audits. A lawyer by training - admitted in Hong Kong and NSW, Australia - Hamish previously worked with UK Magic Circle Firm Linklaters in Hong Kong, and has over 10 years' experience in the legal and regulatory fields. He has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China regulatory pathways and registration points, he currently lives in Hong Kong and specializes in NMPA registrations and compliance.