Xisca Borrás

Partner at Bristows

Speaker

Xisca is a dual-qualified lawyer in England & Wales and Spain who specialises in all aspects of EU and UK regulatory law in the biopharmaceutical and medical technologies sectors.

Xisca advises on a broad range of regulatory law topics including: regulatory strategies for bringing products to market, product life cycle management, regulatory exclusivities, clinical trials and non-interventional trials, including the implementation of the Clinical Trial Regulation, orphan medicinal products, obligations and rewards in relation to paediatric research including agreeing and modifying PIPs, waivers and deferrals and compliance with agreed PIPs, and parallel trade of medicines. She also advises on the regulatory framework applicable to medical devices and in vitro diagnostics.

Xisca has broad experience in manufacturing and distribution issues, including supply management policies, product shortages and recalls, and compliance with GMP, GDP and labelling requirements. She has supported GCP and GMP inspections, both at national and EU level.

She also advises life sciences companies on the consequences of Brexit, including changes required to ensure business continuity further to the UK’s withdrawal from the EU.

Previously she was an in-house lawyer at a leading innovative biopharmaceutical company, where she provided regulatory law support to all business units and functions at EU and global level, gaining excellent knowledge of the pharmaceutical industry enabling her to bring a strong business approach to her legal advice. Prior to that, she was an associate in the IP litigation team at a magic circle law firm in Barcelona for almost 10 years.