Genevieve Michaux

Genevieve Michaux, of counsel in the firm's Brussels office, specializes in European, French, and Belgian food and drug law. Her experience covers a wide range of matters, including clinical trials, life cycle management, labeling and promotion, regulatory status of borderline products, orphan status, and paediatric requirements and rewards, to name just a few. She regularly advises pharmaceutical companies on important new legislative projects and policy developments in the EU. For example, Ms. Michaux was deeply involved in helping to shape the new EC Pediatrics Regulation. She also has broad litigation experience in life science matters, covering everything from product liability to advertising and promotion. A regular participant in international food and drug conferences, she has published numerous articles on food and drug law. According to the Who's Who Life Sciences (2011) guide, sources describe Ms. Michaux as "fabulous."

Representative Matters

· Regulatory audit of European subsidiaries of a large US pharmaceutical company.

· Assisting pharmaceutical companies on implementation of EC pharmaceutical law in EU candidate countries.

· Regulatory due diligence for a large French medical device company.

· Representing a large US medical device company in a product liability case.

· Prepared and negotiated lease agreements for US companies or associations establishing operations in Belgium.

· Advised a Swedish medical device company on Belgian employment and distribution matters.

Honors and Rankings

· PLC Which Lawyer?, Life Sciences - Regulatory, EU (2012)

· Who's Who Legal, Life Sciences (2011-2012)

Pro Bono

· Establishment of a Belgian branch for a large US lobbying association.

Memberships and Affiliations

· Brussels Business Mediation Centre, Mediator

Publications

· "Revision of the Rules on Pricing and Reimbursement of Medicines (the "Transparency Directive") in the European Union," Covington E-Alert (3/1/2012), Co-Author

· "France - A Revolution for the Medical Devices Industry," Covington E-Alert (2/13/2012), Co-Author

· "France - A "Sunshine Act" for the Healthcare Industry," Covington E-Alert (1/20/2012), Co-Author

· "The Nycomed Ruling - For General Diagnostic Products Only," Regulatory Affairs Journal (January 2012), Author

· "The Paediatric Regulation: It's Time for the European Commission and EMA to Change Their Interpretation of the Legal Provisions," Regulatory Affairs Journal (July 2011), Author

· "Advertising of Medical Products and Summary of Product Characteristics (SmPC) Before the European Court of Justice," Covington E-Alert (5/9/2011), Co-Author

· "Aesthetic Devices: Is Specific EU Legislation Needed?," Regulatory Affairs Medtech (September/October 2010), Author

· "EU Orphan Regulation - Ten Years of Application," Food and Drug Law Journal (April 2010), Author

· "Practical Commentary on Regulation (EC) No 141/2000 (Orphan Regulation)," Commented Codex Pharma - Public Health in Belgium (Medicinal Products), Codex of Directly Applicable European Texts (May 2009), Author

· "Practical Commentary on Regulation (EC) No 1901/2006 (Paediatric Regulation)," Commented Codex Pharma - Public Health in Belgium (Medicinal Products), Codex of Directly Applicable European Texts (May 2009), Author

· "La publicité et l'information relative aux médicaments en droit pharmaceutique européen," European Journal of Consumer Law (February/March 2009), Author

· "Pediatric Exclusivities in Europe - A Quest for the Grail?," Food and Drug Law Journal (2009), Author

· "European Employment Law Briefing - The Sex Discrimination Act 1975 (Amendment) Regulations 2008 ("the Regulations")," Covington E-Alert (4/10/2008), Co-Author

· "Les interdictions relatives aux expérimentations animales en cosmétologie - Quel champ d'application," Revue du Droit de l'Union Européenne (March 2008), Author

· "European Employment Law Briefing," Covington E-Alert (2/4/2008), Co-Author

· "HR Legal Briefing," Covington E-Alert (9/28/2007), Co-Author

· "EU Harmonisation of Advanced Therapy Medicinal Products," Regulatory Affairs Journal (August 2007), Author

· "Europe's Plans to Fine Drug Companies," Regulatory Affairs Journal (May 2007), Author

· "Protection des médicaments," Répertoire Notarial, T.II, Liv. 5, Droits Intellectuels (May 2007), Author

· "The EC Paediatrics Regime - Implications for the Industry," Covington E-Alert (12/14/2006), Co-Author

· "Making the Paediatric Regulation Work," Regulatory Affairs Journal (November 2006), Author

· "Advanced Therapies in the EU," RAJ (April 2006), Co-Author

· "Increasing Interplay Between Regulatory Procedures and Intellectual Property Rights," Global Counsel, Life Science (2006-2007), Co-Author

· "La protection administrative des données, L'hydre de Lerne du droit pharmaceutique européen," Revue Trimestrielle de Droit Européen, p. 1 - 212, No 1 (2006), Co-Author

· "Data Exclusivity under the EU's New Pharmaceutical Legislation," Regulatory Affairs Journal (December 2005), Co-Author

· "La réforme du droit pharmaceutique européen," Contrat, Concurrence, Consommation (July 2005), Author

· "Droit pharmaceutique - Quels changements majeurs au niveau européen?," Conference EFE, Panorama de droit pharmaceutique (June 2005), Author

· "Promoting paediatric drug research in the U.S. and the European Union," Regulatory Affairs Journal (June 2005), Co-Author

· "Research Biobanks and Data Privacy," Regulatory Affairs Journal (February 2005), Co-Author

· "La libre circulation des médicaments dans l'Union Européenne," L'Europe et les soins de santé, Larcier (2005), Author

· "Projet de Règlement relatif aux médicaments pédiatriques," Droit & Pharmacie (December 2004), Author

· "Panorama de droit pharmaceutique européen - 2000 à 2005," Journal des Tribunaux de droit européen (November 2004), Co-Author

· "HR Legal Briefing," Covington Report (October/November 2004), Author

· "Herbal Remedies," Life Sciences Law & Business (October/November 2004), Co-Author

Presentations and Speeches

· "Legal Aspects of Paediatric Trials," ECCRT, Paediatrics Conference (Brussels, November 2011)

· "Overview of Approval Process for New drugs and Medical Devices," Seton Hall - Science Po, European Healthcare Compliance Ethics & Regulation Program (Paris, November 2011)

· "Réglementation des Biosimilaires," Société Marocaine des Maladies de l'Appareil Digestif (Rabbat, October 2011)

· "European Pharmaceutical Regulatory Environment," European Centre of Regulatory Affairs Freiburg (EUCRAF) (Frieburg, September 2011)

· "How Clinical Trials Can Contribute to Europe's 2020 Agenda," DIA, 47th Annual Meeting (Chicago, June 2011)

· "Maximising Exclusivity for New Medicinal Products in light of Regulatory and Case Law Developments," Conference C5, Pharma Patent Lifecycles (London, June 2011)

· "Droit pharmaceutique européen - Derniers développements légaux et jurisprudentiels," Panorama de droit pharmaceutique, EFE (Paris, June 2011)

· "Product Information and Liability," DIA, Product Information Forum (London, June 2011)

· "The Legal Aspect of the Orphan Medicinal Product Designation: Market Exclusivity," Worshop on Orphan Medicinal Products in the European Union: from Designation of Orphan Status to Market Exclusivity Post-Approval, World Orphan Drug Summit (Frankfurt, May 2011)

· "Internet Advertising," Annual Conference on European Pharmaceutical Law, Academy of European Law (ERA) (Brussels, April 2011)

· "Paediatric Regulation - Legal Aspects," Seminar on Specific Considerations for the Development and Authorisation of medicinal products for Children, European Centre of Regulatory Affairs Freiburg (EUCRAF) (Freiburg, April 2011)

· "Future of the Paediatric Regulation" and "Legal Issues Raised by Research Biobanks?," DIA, 23th Annual EuroMeeting (Geneva, March 2011)

· "Réglementation des Biosimilaires," 9ème Congrès National de Néphrologie (Marrakech, March 2011)

· "Orphan Drugs - 10 Years of Application," C5 Conference, EU Pharma Law and Regulation (London, November 2010)

· "Understanding Clinical Trials and Procedures," C5 Conference, European Pharmaceutical Regulatory Law (London, September 2010)

· "Update on the Regulatory Protections Available to Extend your Patent Lifecylces," Conference C5, Maximising Pharma Patent Life Cycle (London, June 2010)

· "Maximising Exclusivity for New Medicinal Products in light of Regulatory and Case Law Developments," Conference C5, Pharma Patent Lifecycles (London, June 2010)

· "Droit européen - Panorama 2008-2010," Conférence EFE, Panorama de droit pharmaceutique 2010 (Paris, June 2010)

· "SPC Extension," Chair, DIA, 22th Annual EuroMeeting (Monaco, March 2010)

· "Interactions Between the Regulatory Regime and the Legal Principles Governing Intellectual Property, Competition and Product Liability - For Non-Lawyers Tutorial," DIA, 22th Annual EuroMeeting (Monaco, March 2010)

· "Advanced Therapy Products - What Products are Excluded?," DIA, 22th Annual EuroMeeting (Monaco, March 2010)

· "Does the Proposal on Information to Patients Achieve a Balance Between Patient Expectations and Legal Restrictions?," 22th DIA Annual EuroMeeting (Monaco, March 2010)

· "Data Exclusivity - Update," Ark Conferences, Pharma Law Master Class (London, December 2009)

· "Paediatric Regulation - Update," Ark Conferences, Pharma Law Master Class (London, December 2009)

· "SPC Extension Strategies," DIA Paediatric Forum, Integrating Paediatrics into Drug Development (London, October 2009)

· "Paediatric Regulation: The Legal Perspective," Management Forum, EU Paediatric Legislation (London, September 2009)

· "Advertising and Information on Medicinal Products," Conference C5, EU Pharma Law (London, June 2009)

· "Droit européen - Produits Frontière : Définitions, enjeux et qualifications," Conférence EFE, Quel statut pour les produits frontières (Paris, May 2009)

· "Impact of Regulatory Data Protection and Other EU Regulatory Developments on FTO Determinations," Freedom to Operate Forum for Pharma & Biotech's - Effective Strategies to Conduct an Effective FTO Analysis and Clear your Developmental Path, Conference C5 (London, April 2009)

· "Patent Strategies in Paediatric Development, Medicines for Use in Children: Consequences of the EU Paediatric Regulation," European Compliance Academy (Berlin, March 2009)

· "Trust and Distrust in the Regulatory Process - A Legal View Point," DIA, 21th Annual EuroMeeting (Berlin, March 2009)

· "Aesthetic Implants - Towards a New Legal Regime?," DIA, 21th Annual EuroMeeting (Berlin, March 2009)

· "Interactions Between the Regulatory Regime and the Legal Principles Governing Intellectual Property, Competition and Product Liability - For Non-Lawyers"," DIA, 21th Annual EuroMeeting (Berlin, March 2009)

· "Quel environnement légal pour la distribution des produits de santé en Europe?," Conference EFE, Logistique et distribution des produits de santé (Paris, November 2008)

· "Understanding the Paediatric Rewards," Conference Informa, Legal and Regulatory Strategies for Lifecycle Management (London, October 2008)

· "Paediatric Regulation: Scope of the Paediatric Obligation and Paediatric Rewards," VIB Conference - Paediatric Drug Development and Clinical Trials (Brussels, September 2008)

· "Suggestions for the Future - Interpretation Issues," DIA Paediatric Forum (London, October 2008)

· "Hatch-Waxman, Exclusivities, and Follow-On Biologics Issues in the IP Due Diligence Context," Conference C5, Pharma/Biotech IP Due Diligence (Amsterdam, October 2008)

· "Overview of the IP aspects of the Paediatrics Regulation," DIA Paediatric Forum (London, October 2008)

· "Règlement pédiatrique : Où en sommes-nous?," Panorama de droit pharmaceutique, EFE (Paris, June 2008)

· "Legal Remedies and Drug Approvals During and After the Approval process in the US and the EU," DIA, 44th Annual Meeting (Boston, June 2008)

· "Regulatory Hot Topics of Pharmaceutical Sector in Europe," TOPRA - Pharmaceutical Law & Healthcare Symposium I (Istanbul, June 2008)

· "Médicaments génériques: quelles problématiques légales et réglementaires?," Panorama de droit pharmaceutique, EFE (Paris, June 2008)

· "Comparing the U.S. and E.C. Statutory Conditions for the Pediatric Obligation and Statutory Requirements for the Pediatric Exclusivity," DIA, 44th Annual Meeting (Boston, June 2008)

· "Produits-frontières : Développements en droit européen," Produits-frontières, EFE (Paris, May 2008)

· "Tutorial - Pharmaceutical Law For Non-lawyers," DIA, 20th Annual EuroMeeting (Barcelona, March 2008)

· "Borderline Products - Update on Legal and Policy Developments in the EC," DIA, 20th Annual EuroMeeting (Barcelona, March 2008)

· "Essais cliniques: quelles règles et quelle évolution des pratiques au niveau européen?," Conference EFE Essais cliniques - comment les mettre en place et les suivre de façon optimale (Paris, January 2008)

· "Quel environnement légal pour la distribution des produits de santé en Europe?," Conference EFE, Logistique et distribution des produits de santé (Paris, November 2007)

· "SPC issues relating to the Paediatric Regulation," DIA, EU Paediatric Regulation : How is it working in practice? (London, November 2007)

· "New paediatric legislation in Europe - Assessment of the key implications for the industry and comparison with the US paediatric regime," Conference Informa, The European Pharmaceutical Law Forum, Understanding European Pharmaceutical law and regulations to optimise your international legal strategy (Washington, DC, October 2007)

· "Droit européen - Panorama 2006-2007," Conférence EFE, Panorama de droit pharmaceutique 2006 (Paris, June 2007)

· "Droit européen - Interactions entre réglementaire et propriété intellectuelle," Conférence EFE, Panorama de droit pharmaceutique 2006 (Paris, June 2007)

· "Droit européen - Produits Frontière: Définitions et enjeux," Conférence EFE, Quel statut pour les produits frontières (Paris, March 2007)

· "Droit européen - Produits Frontière: Comment les autorités européennes assurent l'harmonisation des qualifications et ainsi la libre circulation des marchandises?," Conférence EFE, Quel statut pour les produits frontières (Paris, March 2007)

· "Comment qualifier les produits frontières - Quizz," Conférence EFE, Quel statut pour les produits frontières (Paris, March 2007)

· "The New EC Paediatric Regime," Conference Osney Media, Planning for Paediatric Investigations (Paris, January 2007)

· "Panorama de droit pharmaceutique européen 2005-2006," Conférence EFE, Panorama de droit pharmaceutique (Paris, June 2006)

· "Droit européen - Le projet de règlement concernant les sanctions financières: une épée de Damoclès?," Conférence EFE, Panorama de droit pharmaceutique (Paris, June 2006)

· "Regulation on Medicinal Products for Paediatric Use - Update on the Future Paediatric Rules," Conference IIR, Optimising Paediatric Drug Development (Barcelona, June 2006)

· "Produits biocides: un régime particulier," Conférence EFE, Quel statut pour les produits frontière (Paris, April 2006)

· "Comment les autorités européennes assurent-elles l'harmonisation des qualifications et ainsi la libre circulation des marchandises?," Conférence EFE, Quel statut pour les produits frontières (Paris, April 2006)

· "Droit européen - Médicaments, biocides, dispositifs médicaux, cosmétiques, compléments alimentaires et denrées alimentaires: définitions, enjuex, qualification," Conférence EFE, Quel statut pour les produits frontière (Paris, April 2006)

· "Essais cliniques sur des personnes spécialement protégées et des personnes décédées: quelles particularités du consentement et de l'information," Conférence Euroforum, Essais Cliniques et protection des données patients (Paris, June 2005)

· "Comparing the FDA legislation in the US and the proposed EU regulation from a legal point of view," Conference IIR, Paediatric Clinical Trials (Brussels, June 2005)

· "Le projet de Règlement relatif aux médicaments à usage pédiatrique," Conférence EFE, Panorama de droit pharmaceutique (Paris, June 2005)

· "Quels changements majeurs au niveau européen?," Conférence EFE, Panorama de droit pharmaceutique (Paris, June 2005)

· "Comparing the FDA Legislation in the US and the Proposed EU Regulation from a Legal Point of View," Conference IIR, Pediatric Clinical Trials (Brussels, June 2005)

· "Importation de compléments alimentaires dans le Benelux," Conférence Euroforum (Paris, December 2004)

· "Etiquetage des arômes alimentaires," Conférence Euroforum (Paris, November 2004)