Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on issues surrounding the regulatory approval and marketing of drugs, biologics, medical devices, cosmetics and food both at the European and national level.
Her work covers a wide range of issues, including regulatory status of borderline products, authorisation procedures, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.
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 a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.
- Regulatory advice to many of the major national and multinational pharmaceutical and medical device companies.
- Strategic advice for life cycle management activities.
- Provide advice about various issues raised by the EU Paediatric Regulation.
- Provide advice about issues raised by the EU Orphan Regulation.
- Provide advice on SPC and SPC extension.
- Assistance on the procedure for obtaining a marketing authorisation under the centralised procedure.
- Provide advice about issues raised by ATMPs, at the European and national level.
- Concrete guidance to start-up companies on how to establish themselves in the EU and how to comply with the rules on advertising and on scientific information; combined with detailed advice on regulatory and legal compliance.
- Assisting pharmaceutical companies in setting up named patient/compassionate use programs in Europe.
- Assisting pharmaceutical companies in negotiating and drafting consortia related agreements
- Review of clinical trial and clinical investigation related agreements for various pharmaceutical and medical device companies.
- Advice on product classification issues, including borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.
- Provide advice to pharmaceutical companies and medical devices companies in relation to advertising and promotion of medicinal products and interactions with healthcare professionals.
- Advise on EU and national rules on cosmetics to multinational companies.
Harvard Business School, LLM
Université Libre de Bruxelles, (ULB), magna cum laude
- Brussels, Belgium
- Member of the editorial board of SCRIP Regulatory Affairs
- Mediator with the Brussels Business Mediation Center
- Member of the DIA Advisory Committee for Europe Middle East Africa
- Who's Who Legal, Life Sciences, 2011–2016
- Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology, 2012
- PLC Which Lawyer?, Life Sciences - Regulatory, EU, 2012
- de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study, 1988