Louise Strom's practice focuses on matters affecting clients in the pharmaceutical, medical device, cosmetics and food sectors. Ms. Strom advises on a broad range of regulatory issues that arise in the course of the product life cycle, including clinical research, authorisation, manufacturing and distribution, labeling, pricing and reimbursement, and pharmacovigilance. She advises life science companies on the boundaries of the industry codes of practice, and on UK and EU legislation regarding advertising and promotion.

She is experienced in advising clients on health and nutrition claims, food product classification issues, novel foods regulatory requirements (including in relation to CBD products). She also advises on issues arising in connection with EU and UK regulation of acrylamide, pesticides and organic produce.

Ms. Strom assist clients with preparation and negotiation of various types of agreements, including licence and collaboration agreements, clinical study agreements, supply agreements and pharmacovigilance agreements. She also advises life sciences companies on their development and implementation of global and regional compliance programmes.

Ms Strom advises life science clients on privacy and data protection considerations, including under the EU's General Data Protection Regulation (GDPR). Her experience includes advising on the processing of study participants' data, preparing data protection notices and assessing the privacy impact of new technologies.

Ms. Strom maintains an active pro bono practice and regularly advises charities and NGOs on a wide range of legal and strategic matters. She is a member of the firm’s Pro Bono Committee and helps to coordinate UK pro bono matters.

Before joining the firm, Ms. Strom trained and worked in the London and Brussels offices of a leading global law firm, where she focused her practice on dispute resolution. She has also worked in-house at a major financial institution and at a UK regulatory body.

Experience

  • Pharmaceutical companies with respect to promotional activities: advising on materials' compliance with UK/EU regulations and industry codes; preparing training materials on a range of promotional issues; participating in regular Medical-Legal Reviews; assessing product claims; coordinating multi-jurisdictional projects (e.g. regarding website requirements, off-label use, pricing and reimbursement); advising in relation to allegations of infringement of promotional rules.
  • Amicus Therapeutics, Inc. (Case T-33/17) in its European General Court case in relation to transparency of clinical trial data and access to documents held by the EMA.
  • A generics manufacturer on a potential challenge of requirements under the Falsified Medicines Directive.
  • A pharmaceutical company on regulatory and data protection requirements concerning re-consent of clinical trial subjects.
  • A global pharmaceutical company on EU regulatory reporting requirements applicable to combination products.
  • A global organisation on the legality of intra-organisational data sharing and transfers under the GDPR.
  • Evaluation of pharmaceutical companies' internal procedures and commercial contracts for EU/UK regulatory compliance.
  • Submissions to a UK public inquiry (product liability).
  • A global consumer goods company on health and nutrition claims under EU and UK rules.
  • A family in the inquest into the death of their seven-day-old son, conducted under Article 2 of the European Convention of Human Rights due to the systematic and structural failings at the Trust, and which amounted to neglect.
  • A number of life sciences and technology companies on mHealth and related issues.
  • Various pharmaceutical companies on requirements to hold manufacturing, import and wholesale distribution authorisations.
  • Companies on import and marketing of CBD-containing foods and cosmetics.
  • Multi-national pharmaceutical companies in relation to the EU and UK regulatory requirements applicable to clinical trials.
  • Various pharmaceutical companies in relation to drafting and negotiation of commercial agreements (e.g., clinical trial agreements, non-interventional study agreements, collaboration agreements and supply agreements).

Perspectives

EU Medical Devices Regulation: implementation progress during the pandemic
BioSlice Blog
EU MDR implementation: new guidance and implications of the deferral
BioSlice Blog
Ensuring GDPR Compliance in the Life Sciences Sector: Key Trends, Developments and Implications for mHealth
Client Webinar, Arnold & Porter
Two months to go: Latest on the implementation of EU MDR (Part 2)
BioSlice Blog
STOP PRESS! Possible delay to the EU MDR
BioSlice Blog
More

Credentials

Education
  • MA, Medical Ethics and Law, King's College London, 2015, with distinction
  • Legal Practice Course, BPP Law School, 2010, with distinction
  • LLM, Cambridge University, 2008
  • LLB (Hons), Durham University, 2007, First Class
Admissions
  • England and Wales
Activities
  • Member, Food Law Group
Languages
  • Swedish
Overview

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