The Lawyer Network is delighted to announce that Geneviève Michaux of 'Hunton & Williams LLP' has joined the Lawyer Network. Geneviève has joined the Lawyer Network as our exclusive Life Sciences member in Belgium.
Geneviève is a Belgian- and French-qualified lawyer who focuses on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food in Europe, both at the Union and national level.
Geneviève focuses on European, French, and Belgian food and drug law, with particular emphasis on pharmaceuticals and medical devices. Her work covers a wide range of issues, including regulatory status of borderline products, clinical trials, life cycle management, labeling and promotions, and issues raised by specific categories of medicinal products, such as orphan or advance therapy medicinal products. Geneviève provides assistance to pharmaceutical companies on important new legislative projects and policy developments in the EU and has, among other matters, helped shape the new EU Paediatric Regulation. 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 a leading regulatory lawyer in legal directories and by many organizations, such as Who's Who Legal, Life Sciences, 2012. She has published many articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.
Relevant Experience
- 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.
- 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.
- 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.
If you have a requirement in this area, please get in touch with Geneviève directly or with the Lawyer Network committee:
Geneviève's Profile
info@thelawyer-network.com
We welcome Geneviève to the network and look forward to working with her on future transactions.
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