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Brian Kelly is an associate in the London Life Sciences group, whose practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law and product liability and safety.
Mr. Kelly’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice.
Mr. Kelly has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.
Mr. Kelly is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.
Mr. Kelly is an honorary lecturer at University College London.
Representative Matters
- Advise on eHealth and health information issues to clients in the software, telecoms and life science industries.
- Represented clients in UK and EU judicial review proceedings and other administrative actions, in particular relating to health claims on foods, transparency of clinical trial reports, data exclusivity.
- Successfully represented clients in relation to advertising and labeling disputes before the Advertising Standards Authority and Prescription Medicines Code of Practice Authority (PMCPA).
- Administrative and procurement law challenges to healthcare-related tender decisions.
- Advice and successful representation before the National Institute for Health and Clinical Excellence (NICE).
- Regulatory advice to life sciences companies on establishing joint working and risk-sharing relationships with the NHS in England and Wales.
- Advising food clients on general and specialist EU matters involving health and nutritional claims, PARNUTS, novel foods, genetically modified foods, borderline/classification issues and ingredient reviews.
- Advising and co-ordinating international food and cosmetic safety matters and recalls.
- Regulatory due diligence for a number of food, drug and cosmetic companies.
Previous Experience
- Trained with Covington & Burling LLP
- Schering-Plough Limited, seconded to the in-house legal team
- Science and Technology Reporter for Clinica World Medical Technology News
- Clinical News Editor for Pulse, a national medical newspaper
Honors and Rankings
- Chambers UK, Product Liability - Mainly Defendant (2013)
- Legal 500 UK, Product Liability (Food) (2012)
- Medical Journalist of the Year, UK Medical Journalists’ Association Awards (November 2002)
Pro Bono
- Represented a couple in challenging a decision of a UK health authority to refuse medical treatment.
- Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
Publications and Speeches
- "Regulation of Mobile Medical Applications in the USA and the EU," Journal of Medical Device Regulation (August 2013), Co-Author
- "New Regulations on Food Additives, Flavourings and Enzymes," Food, Nutrition & Health Claims Legislation in Europe (4/30/2013)
- "Commercializing Nanotechnology," Drug Delivery Technologies & Formulation (9/6/2012)
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