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Brian Kelly is an associate in the London Life Sciences group, whose practice focuses on food and drug law, public and administrative proceedings, internal investigations, European Union law and product liability and safety. He has a particular interest in advising nano-based companies in the life sciences sector.
Mr Kelly’s advice on general regulatory matters includes borderline determinations, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, product life cycle management and anti-bribery and corruption advice. He has also advised on EU and national laws governing clinical research, data protection, the regulatory status of borderline products, regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.
Mr. Kelly is an honorary lecturer at University College London.
Representative Matters
- Advising pharmaceutical and medical device companies on borderline determinations at the European Union and national member state level.
- Conducting internal investigations and compliance audits for a number of pharmaceutical, medical device and consumer product companies.
- Successfully defending a pharmaceutical company in proceedings before the UK Prescription Medicines Code of Practice Authority (PMCPA) in relation to an innovative risk share scheme.
- Advising several pharmaceutical and medical device companies on compliance with applicable marketing laws and codes of practice.
- Representing a pharmaceutical company before the Medicines and Healthcare products Regulatory Agency (MHRA) regarding pharmacovigilance obligations and patient registries.
- Advising an international consumer products company on the recall of a cosmetic.
- Conducting appeals on behalf of pharmaceutical companies before the European Medicines Agency on orphan designation and marketing authorisation applications.
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
- Media Consultant for several leading pharmaceutical companies
Honors and Rankings
- Medical Journalist of the Year, UK Medical Journalists’ Association Awards (November 2002)
Pro Bono
- Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
Memberships and Affiliations
- Medical Journalists’ Association
Publications and Speeches
- "Sensor and Instrumentation," ESP KTN's Advances in non-invasive biosensing techniques for medical diagnostics and monitoring (9/7/2011)
- "eHealth Issues," Mobile Healthcare Industry Summit 2011 (September 2011)
- "Nanomedicines: Regulatory Challenges and Risks Ahead," Clinica (June 2011), Author
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