Alison co-heads our international Life Sciences and Healthcare group. She works with international life sciences companies to cut through the complexity of EU regulation of medical devices and pharmaceuticals, and get their products to market.
In a career of over 20 years, Alison has helped hundreds of life sciences companies manage the range of legal challenges involved in commercialising medical devices and medicinal products. She combines an encyclopaedic knowledge of the EU and UK life sciences regulatory environment with an analytical understanding of strategy and business in the life sciences sector.
Alison provides sophisticated advice on regulation, compliance and commercialisation, as well as intellectual property transactions. On a number of occasions, she has successfully persuaded regulators and notified bodies to reconsider and ultimately overturn their decisions, allowing her clients to commercialise new products.
Alison supports clients on outright acquisitions and licences, as well as in due diligence for sizeable corporate transactions and listings. She also helps clients navigate the nuances of structuring and negotiating arrangements with various commercial and health care partners within the complex framework of EU regulations, national laws and industry and deontological codes.
Her clients praise the pragmatism and commercial awareness she brings to every legal challenge and transaction, as well as her bright and personable working style. She is an accomplished leader, having built new life sciences practices for two top-tier London law firms.
|Since 2020||Partner, Taylor Wessing|
|2008 - 2020||Partner & head of life sciences, Fieldfisher LLP|
|1996 - 2008||Associate to Partner, Reed Smith|
|1996||Admitted as a solicitor, England & Wales|
|1994||LPC, York Law School|
|1993||Masters, Law & Economics, University of Oxford (including Hamburg University & Erasmus University, Rotterdam)|
|1992||LLB (Hons) European Legal Studies, Law University of Bristol (including University of Rouen, Fance)|
Advertising medical devices in the EU – do the MDR and IVDR represent a change in EU law?, Journal of Medical Device Regulation, February 2020
Eudamed timelines: unravelling contradictory legislation to understand how the deadlines apply – a lawyer’s view, Medtech Insight, November 2019
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulations, Lexis PSL, November 2019
Distribution and marketing of drugs in England, Thomson Reuters Practical Law, November 2019
Distribution and marketing of drugs in the EU, Thomson Reuters Practical Law, November 2019
Commercialisation of healthcare in the EU, Thomson Reuters Practical Law, November 2019
Commercialisation of healthcare in England, Thomson Reuters Practical Law, November 2019
Complying on time with MDR/ IVDR: what options are open to those in trouble?, Medtech Insight, November 2018
Chair/vice-chair, legal & compliance committee, Association of British HealthTech Industries (ABHI), since 2013
Trustee and company secretary, Bede House Charity, 2008 - 2013
Regulatory Affairs Professional Society (RAPS)
The Organisation for Professionals in Regulatory Affairs (TOPRA)
par plusieurs auteurs
par plusieurs auteurs