Geneviève Michaux

Recognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of regulatory and compliance issues under EU and national pharmaceutical, medical devices, and cosmetic laws and regulations, and advises on significant policy developments in the EU life sciences. She assists clients with broader European and global regulatory and compliance projects, including business expansion in Europe.  

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.

Publications

• Update to the European Rules on advertising medicinal products, Financier Worldwide, October 2025
• A Primer on EU's Updated Human Susbatnce Regulations, Law 360, August 2024
• How International Regulatory Collaboration Can Expedite Pharmaceutical Approvals, Law 360, October 2023
• How to Navigate the EU's New Interim PSA Program, Bioprocess Online, September 2023
• How EU New Pharmaceutical Incentives May Affect US Companies, Law 360, December 2022
• October 2019, “Are the paediatric rewards adapted? “, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020
• May 30, 2019, “The regulation of advanced therapy medicinal products” LexisNexis.
• April 2017, “Pediatric Regulation – A Better application for more efficient incentives,” The European Files, Medicines of the Future.
• September 2016, “Should Anthroposophic Medicinal Products Be Regulated in Europe?” Journal of European Health Law
• June 8, 2016, “Demonstrating Significant Benefit For Orphan Medicines – Is It Time For A Drastic Change?” Scrip Regulatory Affairs.
• April 2016, “EU Pediatric Rewards – More Questions than Answers,” Scrip Regulatory Affairs.
• February 2016, “The Need For Clarification On Post-Market Requirements For Pediatric Medicines,” Scrip Regulatory Affairs.

Speaking Engagements

• September 9, 2019, “Summary of Key EUCJ Decisions,” European Pharmaceutical Law Academy.
• June 5, 2019, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.
• September 10, 2018, “ATMP Regulatory Framework,” European Pharmaceutical Law Academy, Cambridge, UK.
• June 2018, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.
• May 15, 2018, “International Labeling Regulatory Requirements,” co-presented with Hank Bullock, 8th Annual Medical Device & Diagnostic Labeling Conference in Chicago, IL.
• March 21, 2018, Workshop on Pediatric Regulation and SMi in London.
• March 2018, ATMPs – Challenges and Promises, ERA, EU Pharmaceutical Law.
• November 2017, Borderline issues, Congrès Parfums & Cosmétiques, Enjeux réglementaires, Chartres.
• September 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.
• September 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).
• June 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London. 
• March 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.
• March 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.
• November 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.
• April 2016, “Protection for Mature Product,” DIA, 28th Annual EuroMeeting, Hamburg.
• April 2016, “Interactions between regulatory and intellectual property, product liability and data privacy,” DIA, 28th Annual EuroMeeting in Hamburg.