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Bonnie Clemence
Senior Associate

Bonnie Clemence

Languages
  • English

Bonnie is a Senior Associate in the CMS Life Sciences group. She specialises in the life sciences and consumer products sectors, and has over 10 years’ experience advising clients on the regulatory frameworks governing medicines, medical devices, in vitro diagnostic devices, and cosmetics.

Bonnie advises on strategic, regulatory, compliance and liability issues arising at all stages of the product life cycle, including business models, research and development, clinical trials/investigations, borderline classification, marketing authorisation/conformity assessment, regulatory protections, market access, supply chains, pharmacovigilance, post-market surveillance, labelling/IFU, advertising and promotional activities. She also manages and co-ordinates international regulatory and compliance advice.

Relevant experience

  • A number of life sciences clients in relation to evolving 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.
  • Various software companies on the legal status of clinical use software and potential medical device / IVD (or accessory) status for a variety of different software and AI products, including surveys of legal status across multiple regions.
  • A number of life sciences clients on the implications of the MDR/IVDR, including changes to scope, medical device classification, clinical evidence requirements, conformity assessment and post-market surveillance obligations.  
  • A number of medical device companies in relation to product launches or expansion into new markets, including optimal structuring of supply chains.
  • Several companies in relation to 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.
  • Various pharmaceutical and medical device companies on compliance with the UK Bribery Act and with the ABPI Code of Practice / EFPIA Code of Practice and the ABHI Code of Ethical Business Practice  / MedTech Europe Code of Ethical Business Practice and in relation to investigation of violations and complaints.
  • Several companies on strategic investments in and acquisitions of life sciences and technology companies, including targeted regulatory due diligence and advice on regulatory contractual matters.

Memberships & Roles

Education

  • 2012 - LPC, The College of Law, Moorgate.
  • 2011 - GDL, The College of Law, Moorgate.
  • 2009 – BA Hons, Cambridge University, Cambridge.
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