Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.

Recognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, 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.[[--readmore--]]

Geneviève’s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising 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. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. 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 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 borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.

Geneviève has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.

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

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.