Jane is a Counsel in the London office and focuses on regulatory compliance and commercial agreements in the life sciences and food sectors. Jane advises on legal and regulatory requirements that apply during the product lifecycle, including clinical trial requirements, early access schemes, marketing authorisations, manufacturing and distribution licences, CE marking, product labelling, product composition, advertising and marketing activities, and pricing and reimbursement. Jane also advises on a wide range of commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements, as well as helping clients to resolve issues with UK enforcement authorities and regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA), Advertising Standards Authority (ASA), Food Standards Agency (FSA) and Trading Standards.
Jane combines commercial acumen with deep regulatory knowledge. She understands the business pressures faced by clients, having provided in-house regulatory compliance and commercial support to a major pharmaceutical client and a multinational food company. Jane provides "clear responses with business impact" Chambers UK.
This Practice Note introduces the regime for regulation of the manufacture and sale of medical devices in the EU under Directive 93/42/EEC on medical devices, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices. It explains how devices are classified, assessed (by completion of a conformity assessment) and CE marked. This Practice Note also considers the advertising and promotion or medical devices, counterfeit medical devices, 3D printing and mobile health.
This Practice Note explains the concept of regulatory data protection (RDP), also known as ‘data exclusivity’, provides guidance on how RDP works in practice and the impact it has on the entry into the market of generic and biosimilar medicinal products.
If you expected to see yourself on this page, click here.
0330 161 1234