Jamie regularly advises on all aspects of compliance with a wide range of UK and EU life sciences regulatory frameworks, in particular those concerning medicinal products, human tissue, clinical trials, medical devices and artificial intelligence.

Recent areas of particular activity have included:

• Navigating the complexity of the EU Medical Device Regulation transitional periods and tracking the pending introduction of an updated UK medical devices regulatory framework.
• Understanding the implications of Brexit, the Northern Ireland Protocol and the Windsor Framework.
• Preparing for the entry into force of the EU AI Act.

As well as advising on statutory regulatory requirements, Jamie advises on a variety of self-regulatory codes of conduct for the life sciences industry which govern advertising and industry interaction with the healthcare sector. He regularly represents clients in the context of complaints made under such codes of conduct to organisations such as the ABHI and PMCPA.

Jamie regularly provides specialist due diligence support on a variety of corporate transactions in the life sciences sector.

Some of Jamie’s work highlights include:

• Reviewing compliance of a large US tech company’s health software portfolio with UK and EU medical device laws.
• Advising an innovator pharmaceutical company on the existence and duration of Regulatory Data Protection periods for its portfolio in the UK and EU.
• Acting for a major MedTech company in relation to a complaint to the ABHI against a competitor regarding misleading comparative advertising claims.
• Specialist advice in relation to a corporate asset sale of a worldwide portfolio of Marketing Authorisations for medicinal products.
• Negotiating clinical trial-related agreements and documentation with CROs.

Jamie is currently on a part-time secondment at a market-leading MedTech company, advising on European medical device advertising compliance.