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  • Alison Dennis
Alison Dennis
Alison Dennis

Alison Dennis

合伙人

  • 伦敦 英国
+44 20 7300 4725
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奖励

Legal 500 UK 2025

Leading partner

Scroll to featured award

Alison co-heads our international life sciences team. 

Alison is recognised as a top regulatory and transactional life science lawyer in Europe and is qualified in England & Wales and the Irish Republic. She works with mid-sized and large medical device and pharmaceutical manufacturers, helping them to design new product offerings to meet regulatory requirements and to facilitate product commercialisation across the UK and EU. Alison frequently negotiates optimal positions for pharma and medical device companies with regulators such as competent authorities, notified bodies, and industry bodies with voluntary codes.

Alison’s analytical understanding of strategy and business comes from over 25 years helping hundreds of life sciences companies manage the range of legal challenges that arise in putting medicinal products and medical devices on the market in Europe and beyond. Her experience has encompassed complex regulatory matters, corporate, competition, IP and compliance with anti-bribery laws and codes. She applies this breadth of knowledge to help companies achieve their business goals at the same time as regulatory and compliance requirements and she is consequently known for providing highly pragmatic advice.

Alison's recent experience includes advising:

  • For multiple medical devices and IVD clients, drafting Field Safety Notices and Field Safety Corrective Actions and negotiating these with regulators across many European countries, the Middle East and Asia: engaging with the TW products team in undertaking any consequential recall of products.
  • An international pharmaceutical company on responding to a PMCPA complaint and successfully appealing the decision.
  • A medical device company on an investigation of the activities of its sales and marketing teams in relation to engagements with HCPs and HCOs, undertaking the investigation and advising on changes to policies, processes, procedures and training.
  • A pharmaceutical company on gearing up with sales agreements and compliance activities, including extensive training, before placing their pharmaceutical product and their medical device on the market across Europe.
  • An IVD company on interactions with the MHRA and with government departments: steering a course to settle regulatory issues on a commercially acceptable basis.
  • On the VPAS scheme for pharmaceuticals, and regarding the size of the rebates payable under it.
  • Acting on the disposal of assets from an international manufacturer to a large medical device company, dealing with the issue of "frozen" MDD certificates and working with the notified body to facilitate the acquisition from a regulatory perspective.

Thomson Reuters, Stand-out Lawyers 2022 - Identified by in-house lawyers as one whom they rated above all others that they interact with.

专长

执业领域和服务团队

数据和网络
版权与媒体法
信息技术
专利与创新
品牌与广告业
商业和消费者合同
竞争、欧盟与贸易事务
法人犯罪与合规性
纠纷和调查
Regulation
产品合规性
产品责任与产品安全
交通运输
欧盟法律与欧盟程序法
医疗监管
反贿赂与反腐败
监管执行
专利与专有技术争议解决
专利与专有技术商业协议的起草和谈判
科技诉讼业务团队
广告与不正当竞争
产品上市战略
关于合同安排的架构及转让相关的咨询服务
并购交易中的合同、技术、数据和知识产权尽职调查
各种复杂商业 (B2B) 合同的起草和谈判
各种消费 (B2C) 合同的起草和协商
与合同安排相关的监管问题
合作与合资
分销与竞争法
与知识产权相关的竞争法
合规性
健康数据
全新的数字产品和数据
生命科学监管咨询

行业

酒店与休闲
房地产
数字医疗
医疗器械
生命科学和医疗保健类房地产
生物技术
医疗保健和社会保障以及投资者
制药
机器学习

Advertising Medical Devices European Comparison Tool

Looking to promote your medical device products in Europe? Access our comparison tool to manage regulatory challenges across multiple jurisdictions. 

Access here

CV

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, France)

职业发展

Since 2020 Partner, Taylor Wessing
2008 - 2020 Partner & head of life sciences, Fieldfisher LLP
1996 - 2008 Associate to Partner, Reed Smith

教育

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, France)

Publications

Pharmaceutical Advertising 2022, Chambers Global Practice Guides, April 2022

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

会员资格和附属关系

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)

 

语言

French

奖励

Legal 500 UK 2025

Featured

Leading partner

Managing Intellectual Property – IP Stars 2024

Patent and transactions star

Chambers and Partners UK 2024

Life Sciences regulatory - Band 2: “Alison Dennis is very experienced and an excellent lawyer.”

Chambers and Partners UK 2023

Life Sciences (transactional) - Band 3: Alison Dennis is called on by leading sector clients to advise them on all manner of high-value transactions and also on the compliance of their products with various regulatory regimes. She acts for market leaders in biotech, medical devices and pharmaceuticals. "Alison Dennis is very good on medical devices."

Life Sciences (regulatory) - Band 2: Alison Dennis is called on by leading sector clients to advise them on all manner of high-value transactions and also on the compliance of their products with various regulatory regimes. She acts for market leaders in biotech, medical devices and pharmaceuticals. "Alison Dennis is very good on medical devices."

Alison has been recognised in The Lawyer's Hot 100 in 2022, for the second time, having been selected previously in the 2013 cohort.

Life Sciences - Transactional: "Alison Dennis is called on by leading sector clients to advise them on all manner of high-value transactions and also on the compliance of their products with various regulatory regimes. She acts for market leaders in biotech, medical devices and pharmaceuticals." "Alison Dennis has always been a knowledgeable and resourceful life science lawyer."

IP - contentious and non-contentious

Product liability - defendant

Product liability - defendant

最新新闻和观点

View Alison's insights
点击此处了解更多
酒店与休闲

Updated post-market surveillance (PMS) rules for medical devices in the UK: differences from the EU regulations

2025年5月1日

作者 Alison Dennis 以及 Alice Matthews

Synapse - AI in Life Sciences

UK approach to regulating AI in Life Sciences

As AI innovation in the life sciences sector continues at pace, the Medicines and Healthcare products Regulatory Agency (MHRA) publishes principles and guidance in relation to software-as-a-medical-device which includes the application of AI.

2025年3月6日

作者 Alison Dennis

1 / 10 观点

点击此处了解更多
Synapse - AI in Life Sciences

Selecting your AIA notified body

Manufacturers/providers of medical devices that, according to the EU AI Act, include a high-risk AI system (HRAIS) require a notified body assessment of their technical documentation and/or quality management system should urgently consider which notified body to appoint.

2025年3月6日

作者 Dr. Stefanie Greifeneder 以及 Alison Dennis

6 / 10 观点

点击此处了解更多
View Alison's insights

Related news & insights

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International Data Transfers Under Pressure: DPF in Question, New U.S. Rules Take Effect, and China Back in Focus

2025年5月15日
Briefing

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品牌与广告业

UK to maintain current exhaustion of rights regime

2025年5月15日
Quick read

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房地产与建筑业

The Procurement Act 2023: new powers for investigations and debarment from all public procurement

2025年5月14日
In-depth analysis

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3D shape of TETRA BRIK valid despite technical aspects

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In-depth analysis

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In-depth analysis

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品牌与广告业

Genuine use in the UK where services provided outside the UK

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In-depth analysis

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房地产与建筑业

Building Safety Levy to start from October 2026

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In-depth analysis

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品牌与广告业

Vast numbers of EUTMs and comparable UKTMs soon at risk: brand owners need to act now

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In-depth analysis

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品牌与广告业

UKIPO to abolish series marks plus other plans

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Briefing

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点击此处了解更多
Apple ESG
环境、社会和公司治理 (ESG)

Apple faces European class action

2025年5月8日
Briefing

作者 Karlijn van Laar

点击此处了解更多
View all insights

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