78 Cannon Street
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.
- 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.
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)
- 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