With just over three months to go before the United Kingdom ceases to be a member of the European Union, companies in the life sciences sector must ensure that they are prepared for the changes and aware of how these may affect their business.
In this webinar, Bristows’ experts will examine the regulatory law implications of Brexit for the life sciences industry, with a focus on medicinal products, medical devices and product liability. In particular, they will provide insight into the key regulatory law considerations for stakeholders in the life sciences sector, to ensure business continuity and minimise risks after Brexit in both the European Union and the United Kingdom. They will also cover any progress made on the withdrawal agreement and any transitional period implications. At the end of the presentation, they will be available to answer your questions.
The talk is aimed at in-house counsel in the pharmaceutical, medical devices and health sectors, as well as European, Asian and US lawyers who want to keep up to date with the UK life sciences regulatory landscape.
Gregory Bacon, partner
Gregory Bacon is an experienced IP and regulatory lawyer with a particular focus on the life sciences sector. His extensive scientific background gives him a valuable understanding of technical issues that can underlie IP and regulatory matters, particularly in the life sciences field. He has advised and represented clients on small molecule pharmaceuticals, biologics (originators and biosimilars), medical devices (traditional and software), as well as in the chemicals, technology, shipping and online publishing sectors.
Xisca Borrás, of counsel
Xisca Borrás joined the Bristows regulatory team in October 2018 as of counsel and specialises in all aspects of EU and UK law in the biopharmaceutical sector. She was previously an in-house lawyer at Pfizer, where she advised on EU regulatory law with a particular focus on clinical trials and non-interventional studies, compassionate use of medicines, orphan medicines, the Paediatric Regulation, regulatory exclusivities, regulatory strategies and business transactions. Prior to that, she was an associate in the IP litigation team at Clifford Chance in Barcelona for almost 10 years.
Michaela Herron, senior associate
Michaela Herron advises clients in the pharmaceutical, medical device (including software medical device), healthcare, digital health, cosmetic and general consumer product sectors on various regulatory compliance matters, including regulatory approval, labelling, traceability, safety and liability issues. She has advised clients on enforcement action (including the defence of criminal prosecutions) and the implementation and coordination of product withdrawals and product recalls and rectification strategies in multiple jurisdictions. She has also acted on behalf of clients in significant commercial disputes, group product liability litigation, inquests, injunctive relief and judicial review proceedings. Prior to joining Bristows, she worked as a healthcare lawyer in Ireland and the United Kingdom.
Eleanor Denny, associate
Eleanor Denny advises on both contentious and non-contentious regulatory matters in the European Union and the United Kingdom. She advises clients in relation to regulatory compliance on a broad range of subjects, including on medicinal products, medical devices, cosmetics and food. In relation to medicinal products and medical devices, for example, she has advised clients on the requirements for authorisation, promotion, market exclusivity/data protection, orphan medicines, paediatric extensions, pharmacovigilance and falsified medicines, as well as clinical evaluation reports, clinical investigations and labelling.