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Portrait ofShuna Mason

Shuna Mason

Partner

CMS Cameron McKenna Nabarro Olswang LLP
Cannon Place
78 Cannon Street
London
EC4N 6AF
United Kingdom
Languages English, German

Shuna Mason is a partner in the Lifesciences group at CMS UK and is the firm’s lead on regulatory and product liability issues.

She specialises in the lifesciences and consumer products sectors, covering pharmaceuticals, medical devices, in vitro diagnostic devices, human tissue, cosmetic and plant protection products.  

Shuna advises companies on regulatory, compliance and liability issues in relation to product lifecycles as well as business models, on both international as well as national issues. She frequently manages and co-ordinates international regulatory, compliance and liability / litigation advice. She is also actively involved in UK and European trade associations in the medical devices and diagnostics sectors, including as an invited member of the MedTech Europe legal affairs focus group and its ethical business code committee and brings a broad perspective on healthcare sector issues when advising clients.

Shuna’s team advises in relation to pre-market development, market authorisation or conformity assessment as well as in relation to (pharmaco-)vigilance and other post-market compliance issue, including postmarket surveillance, field safety corrective action, labelling/IFU and all types of promotional materials and activities, including compliance.

Shuna has extensive experience in handling English product liability disputes and other litigation, including regulatory enforcement and judicial review administrative challenges.  She is also familiar with co-ordinating and managing product liability litigation and recalls across Europe and beyond for manufacturers and insurers.

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Chambers ranks Shuna for regulatory and as a Band 1 individual for product liability.

Shuna Mason leads the firm's regulatory practice and is well known in the medical devices, pharmaceuticals and consumer health products markets. She is also recommended for product liability defence instructions.

Chambers

Shuna is listed in the 2016 edition of Who's Who Legal: Life Sciences – Regulatory.

Relevant experience

  • Evolving lifesciences business models to include eHealth products or connectivity, including advice on borderlines between manufacturer and healthcare provider regimes and triggers for healthcare provider registration requirements (Care Quality Commission or equivalent) and remote healthcare and cross-border healthcare regulatory and liability issues.
  • The legal status of clinical use software and potential medical device / IVD (or accessory) status for a wide variety of different software products, including surveys of legal status across multiple regions.
  • A US-based orphan medicinal product manufacturer on the commercialisation, reimbursement and compliance processes across G5 group countries.
  • A UK R&D company on the implications of the EFPIA Disclosure Code.
  • Takeda Pharmaceutical Company Limited on the integration of its business with that of acquired Swiss drug company, Nycomed A/S.
  • Product borderline issues (drug / device / cosmetic / human tissue / biocide / “unclassified” borderlines) and appropriate product development and marketing strategies, including surveys of viability of different product claims across multiple jurisdictions.
  • A Japanese global pharmaceutical company on the clinical trial insurance requirements across 18 jurisdictions and also for a clinical trials insurer on multi-jurisdictional insurance requirements, policies and certificates.
  • A Japanese pharmaceutical company on the EU labelling implications for generic companies of EU usage patents.
  • Merger partners in the context of a competition inquiry about API and excipient GMP manufacturing requirements.
  • Various pharmaceutical and medical device companies on compliance with the UK Bribery Act and with the ABPI Code of Practice / MedTech Europe Code of Ethical Business Practice and in relation to investigation of violations and complaints, including coordinating compliance systems reviews across multiple jurisdictions.
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Publications

  • Contributed 2 chapters to publication “The Textbook of Pharmaceutical Medicine” (7th edition) published by WILEY-BLACKWELL: “Legal and ethical issues relating to medicinal products” (co-author) and “European regulation of medical devices” (sole author) 
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Lectures list

  • Informa’s Pharmaceutical and Medical Device Labelling Summit in Berlin, October 2015: Claims in promotional materials: legal implications of non-compliance
  • ABHI’s Regulatory Conference in London, September 2015 (Chair): Importers and Distributors: New Roles and Responsibilities under the Medical Devices Regulations
  • Informa’s 23rd EU Pharmaceutical Law Forum in Brussels, May 2014: Review of the EU clinical trials regulation
  • ABHI’s seminar, UDI Systems: The Here and Now of Implementation in London, May 2014: UDI for medical devices in the EU: legal obligations and implications for manufacturers and the supply chain
  • DIA, 26th Annual EuroMeeting in Vienna, March 2014: Development of the EU Regulatory Framework for Companion Diagnostics
  • ABHI’s MedTech Conference in London, October 2013: Chair of Regulatory Session
  • DIA, Combination Products Workshop in Basel, October 2013: Current and Future Regulatory Requirements for CDx
  • DIA, 25th Annual EuroMeeting in Amsterdam, March 2013: Development of the EU Regulatory Framework for Companion Diagnostics
  • ABHI’s Regulatory Conference, the MDD Revision: a definitive overview, in London, October 2012: Revision of the Medical Devices Directives: the Commission’s proposals of 26.9.12
  • MHRA Design Management Workshop in London, 2010: Device Design Management: the current legal parameters
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Feed

08/05/2024
Pharmaceutical advertising regulation and medical device advertising in...
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27/03/2024
Cannabis law and legislation in the UK
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New proposals published for post-Brexit reform of UK HealthTech regulation
IntroductionOn 7th March 2023, the UK Life Sciences Council Advisory Group (the “Advisory Group”) published new proposals to accelerate the delivery of a new UK HealthTech regulatory system, which...
29/06/2021
In View: Life Sciences quarterly update webinar
CMS are delighted to invite you to the next instalment of our Life Sciences quarterly update webinar where CMS experts across the firm will discuss key industry topics impacting, innovating and disrupting...
25/05/2021
Managing investigations: planning pressures and pitfalls video series
With more internal reporting of concerns within businesses thanks to improved training and controls, and with complex regulatory, criminal and HR investigations becoming more commonplace, corporates need...
29/04/2021
Updated CMS Expert Guide to A legal roadmap for Cannabis
2021 is shaping up to be a year of significant developments for the cannabis industry around the globe. Some countries have reformed their regulations on medical cannabis. In January 2021, a set of Rules...
17/03/2021
Watch On-Demand - Managing Investigations Video Series: Reporting to Regulators...
Our latest bitesize video in the Managing Investigations: Planning, Pressures and Pitfalls series is now available to watch on-demand on cms.law. Discussing Reporting to Regulators and Authorities, the...
23/02/2021
Life Sciences Quarterly Update - Brexit Implications for the MedTech Sector
We are delighted to invite you to our life sciences quarterly update webinar, ‘in view’. Our CMS team will be evaluating the wide ranging impacts of Brexit for those operating in the MedTech sector...
18/08/2020
A legal roadmap for Cannabis – updated Expert Guide
The first half of 2020 confirmed that the cannabis industry is a vibrant and constantly evolving sector. Among others, the German authorities announced that medicinal cannabis from cultivations in Germany...
18/06/2020
MHRA releases updated guidance on medical device software and apps
On 4 June 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”) published its updated guidance on medical device stand-alone software, which is intended to clarify the types of software...
30/04/2020
CMS On the Pulse episode #1: A legal roadmap for cannabis law and regulation
The Global Life Sciences & Healthcare Sector Group is delighted to launch its new video/podcast series, On the Pulse. The series brings together CMS lawyers and experts to discuss key industry topics...
28/04/2020
Key considerations for conducting internal investigations remotely
With so many businesses in lock-down, many internal investigations will have to be conducted remotely, with investigation teams, employees, external counsel and other providers working from home for the...