ZINA CHATZIDIMITRIADOU advises life sciences and medtech clients on all aspects of product lifecycle management under UK and EU law. A former scientist, having worked in molecular biology research, Zina brings with her the ability to effectively understand the science. She advises and speaks on cell and gene therapies, market access, digital health and artificial intelligence.
Zina’s practice covers the pharmaceutical, medical device, medtech, biotechnology, food, cosmetics, and novel products (such as cannabidiol or CBD) industries on both advisory and contentious matters.
- Digital health: Zina is particularly active in matters of digital health and advises extensively on the development and use of wearables, novel clinical study designs, telehealth services and pharma-medtech partnerships, as well as on the compliance with the applicable medical device and in vitro diagnostic frameworks. She has a keen interest in the interplay with the evolving artificial intelligence landscape.
- Market access: One key area of Zina’s practice is on drug pricing and designing market access strategies for innovative products including cell and gene therapies, both at national and EU level, enabling early engagement with key stakeholders, coordinating with other jurisdictions and appearing before payers and national agencies.
- EU/UK pharma and IP law: Zina advises companies on the protection and enforcement of their IP regulatory rights, including orphan market exclusivity, regulatory data protection, pediatric rewards, data transparency and product liability. In addition, she provides assistance on compliance with industry and regulatory practice codes and advertising and promotion practices. She has successfully represented clients before the Committee for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO) of the European Medicines Agency, as well as the UK National Institute for Health and Care Excellence for pricing and reimbursement matters. She frequently counsels on promotion and advertising matters, interactions with healthcare professionals, and transparency obligations.
- Advanced therapies: Zina is particularly keen to assist novel products, such as ATMPs, to be developed and provided to patients. This is particularly so through new approaches to approval and market access, but also thought leadership on pathways including real world data/evidence (RWD/RWE).
Zina’s litigation experience includes representing clients before national courts, tribunals, and professional bodies and committees.