Geneviève Michaux

Partner, King & Spalding LLP

Geneviève Michaux is dual qualified in Belgium and France and is a partner in the firm’s FDA and life sciences practice. She is recognised as one of the most highly regarded EU life sciences regulatory specialists. Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drugs laws and regulations, with an emphasis on regulatory mattersinvolving drugs, biologicals, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.

Geneviève has advised on various issues arising out of the EU Paediatric Regulation, the EU Orphan Regulation, the regulations relating to supplementary protection certificates (SPC) and SPC extensions and the Advanced Therapy Medicinal Products Regulation at the European and national level. She also counsels start-ups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance. She assists life sciences companies in forming patient/compassionate use programmes in Europe, negotiating and drafting consortia-related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts and product classification matters such as borderline determination between drugs, medical devices, cosmetics and food supplements, and dealing with local authorities. Geneviève has extensive litigation experience in life science matters, including in terms of product liability and advertising and promotional activities. She is recognised as one of the ‘Most Highly Regarded Individuals’ in the regulatory field by Who’s Who Legal: Life Sciences 2016.