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Up and Coming
Provided by Vladimir Murovec
Life Sciences - EU Regulatory
‣ Regulatory Affairs Professionals Society | RAPS
‣ Healixia
‣ BioWin
Vladimir Murovec is an EU life sciences regulatory and compliance lawyer advising pharmaceutical and biotech companies, medical device and in vitro diagnostic manufacturers, and digital health and AI providers on complex cross border regulatory and compliance matters.
European Union (EU)
His practice spans multinational US and Asian stakeholders navigating EU regulatory entry, established European players, and domestic market leaders.
He focuses exclusively on the life sciences and healthcare sectors. Vladimir’s expertise covers EU and national pharmaceutical law, the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), clinical and post market requirements, GxP and quality systems, and sector specific compliance, transparency and advertising rules.
Vladimir's work encompasses the full product life cycle, from research and development and clinical activities through post market compliance and risk management. Early stage work includes regulatory pathways, EU drug marketing authorisations, device CE marking and conformity assessment, and quality management systems. He also advises on cross border distribution and supply structures, pricing and reimbursement, and promotional / marketing activities and interactions with healthcare professionals and organisations. Vladimir regularly advises on product safety and liability.
He regularly works alongside in house legal, regulatory and compliance teams, drawing on multiple secondments with global pharmaceutical and medtech companies. Vladimir designs and implements compliance programmes, governance structures and internal procedures, including QMS and GxP frameworks, codes of conduct, policies on ethical interactions with healthcare stakeholders and patients, and transparency and anti bribery and corruption controls. He also assists with complex cross border investigations, audits and enforcement matters, and represents both EU and non EU businesses in their dealings with European and national regulators and industry associations.
Vladimir is a frequent speaker at international conferences and industry events on life sciences regulatory and compliance topics, including EU pharmaceutical, medical device and IVD rules, digital health and AI in healthcare. He has taught EU life sciences regulations in business schools and contributes to academic and practitioner publications. He serves as an associate editor of the European Health and Pharmaceutical Law Review (EHPL) and is a member of the Regulatory Affairs Professionals Society (RAPS).
International legal directories, including Chambers, Legal 500 and Who’s Who Legal (Lexology), recognise Vladimir for his work in EU life sciences regulatory and compliance across pharmaceuticals and biotechnology, medical devices and medtech, diagnostics and digital health.
Provided by Chambers
Vladimir Murovec of Osborne Clarke is regularly sought out to advise on regulatory compliance, with particular expertise in medical devices and medtech. He offers further skill in the negotiation of supply, distribution and licensing agreements, as well as reimbursement issues and M&A transactions in the sector.
Provided by Chambers
Vladimir Murovec is very pragmatic and realistic. We can almost copy and paste his advice. He understands our internal considerations and is very specialised in his field.
Vladimir Murovec is very pragmatic and realistic. We can almost copy and paste his advice. He understands our internal considerations and is very specialised in his field.
Provided by Osborne Clarke
Health and Life Sciences