• Restructuring of a large Australian telehealth business to address regulator concerns, involving regulator engagement, responding to professional disciplinary investigations, and redrafting of core operational agreements and policies
• Opinion on inclusion on the AICIS Inventory of cosmetic incorporating human tissue as the active ingredient
• Representing applicant for registration of a post-surgical analgesic on the Australian Register of Therapeutic Goods in challenging TGA decision to refuse registration at the Administrative Review Tribunal
• Legal support for the development of a new women’s health and weight loss telehealth business, including business structuring advice, regulatory advice and drafting commercial agreements covering professional standards, advertising restrictions, and interactions between prescribers, the preferred pharmacy business and wholesalers of prescription medicines
• Campaign to achieve amendments to state medicines legislation, involving drafting position papers, liaison with lobbyist, and building an industry coalition
• Assistance navigating re-structure of member-based peak specialist medical profession peak body, including drafting position papers, presenting at board and general meetings, drafting constitutional amendments and negotiating new agreements with key stakeholders
• Preparation of procurement agreements for IVF providers to acquire donor eggs and sperm from overseas donor gamete banks, and preparation of successful applications to the Victorian Assisted Reproductive Treatment Authority to import donor eggs

Webinars

Therapeutic Goods Act Boundary Issues