Geneviève Micheaux

Partner, Government Matters & Regulation at King & Spalding

Speaker

Geneviève’s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, to labeling, advertising and promotions, distribution and manufacturing. She advises companies with their regulatory strategy for the EU market, helping them to navigate complex EU regulations in particular the Pediatric, Orphan, and ATMP Regulations and to interact with regulators. She also counsels startups 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 programs or distribution chains in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, drafting compliance-related SOPs, reviewing agreements with healthcare professionals, and designing compliant marketing digital platforms. Geneviève has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.

Geneviève also helps life sciences companies with their European and international projects relating to various regulatory and compliance issues such as multi-countries clinical trials, international conferences, and product websites.

Geneviève is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.