Picture of Shuna 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

Show only
11 January 2017
Con­sumer products and re­tail dis­putes and in­vest­ig­a­tions
06/11/2017
Brexit: State of play for Life Sci­ences com­pan­ies
With the UK pre­par­ing to leave the European Uni­on (EU) on 30 March 2019, life sci­ences com­pan­ies are plan­ning ahead for changes to the busi­ness and reg­u­lat­ory en­vir­on­ment. Dis­cus­sions at the EU Sum­mit on 19 Oc­to­ber 2017 primar­ily fo­cused on what are re­garded.
08/07/2016
Our ehealth cap­ab­il­it­ies
12/04/2017
EU Med­ic­al Devices Reg­u­la­tion and In-Vitro Med­ic­al Devices Reg­u­la­tion...
The EU Med­ic­al Devices Reg­u­la­tion and In-Vitro Med­ic­al Devices Reg­u­la­tion (the “Reg­u­la­tions”) were ad­op­ted on 5 April 2017, fol­low­ing a fi­nal vote at the European Par­lia­ment. The Reg­u­la­tions were pro­posed by the Com­mis­sion in 2012 (as dis­cussed in our pre­vi­ous.
06/02/2016
CMS launches Glob­al Product Li­ab­il­ity team in Lifes­ci­ences
30/08/2016
MHRA is­sues up­dated guid­ance on ehealth stand-alone soft­ware (in­clud­ing...
The Medi­cines and Health­care products Reg­u­lat­ory Agency (“MHRA”) has up­dated its guid­ance on stand-alone soft­ware in­clud­ing apps (the “Up­dated Guid­ance”). The Up­dated Guid­ance sets out the MHRA’s in­ter­pret­a­tion of the Med­ic­al Devices Dir­ect­ive (93/42/EEC) and.
16/02/2015
Un­der the Mi­cro­scope: How 2014's leg­al de­vel­op­ments...
15/07/2016
The UK votes to leave: con­sequences for the lifes­ci­ences sec­tor
With the UK hav­ing voted to leave the EU, lifes­ci­ences busi­nesses will now need to give much fur­ther con­sid­er­a­tion to what ef­fect Brexit will have on their busi­ness and take the ne­ces­sary steps to mit­ig­ate any neg­at­ive im­pact and ex­ploit any op­por­tun­it­ies.
27/11/2014
EU Clin­ic­al Tri­als Reg­u­la­tion - New and Ap­proved
07/07/2016
Is it a PAR­NUT? Is it a Medi­cin­al Product? Is it a Food for a Spe­cif­ic...
The PAR­NUTs re­gime which reg­u­lates spe­cial­ist foods has not changed much since it was cre­ated in 1977.   However, since the 1970s the mar­ket for spe­cial­ist foods has grown as­tro­nom­ic­ally and the bound­ary between spe­cial­ist foods and gen­er­al food has be­come much.
01/10/2014
Per­son­al­ised medi­cines - In har­mony?
01/05/2014
The An­ti­dote - Spring 2014
Tak­ing a look at "pharm­er­ging" mar­kets and the re­sur­gence...
07/03/2014
Health and beauty
27/01/2014
The An­ti­dote - Pre­dic­tions for the Lifes­ci­ences sec­tor...