I am an expert in Life Sciences law (including pharmaceutical and medical devices law), as well as intellectual property law and personal data protection in the Healthcare and Life Sciences sectors.
I also advise clients on manufacturing and distribution of medicinal products, e-Health and m-Health projects, conducting clinical trials, development of medical devices (including medical device software), obtaining and using medical data – including for training neural networks, data reuse from participants in clinical trials, as well as the development and implementation of AI/ML tools supporting diagnostic and therapeutic decisions. I conduct training and audits, as well as providing professional advice on good GxP practices (GMP, GDP, GCP). I also advise clients during GMP and GDP inspections by the Chief Pharmaceutical Inspectorate and I represent clients in post-inspection proceedings.
I work for leading international pharmaceutical and medical companies operating in Poland and also for many industry associations.
I am a member of the Polish Association for Good Clinical Practice. In 2023, I joined the governmental Artificial Intelligence Working Group (GRAI) – health and ethics & law sections – which was formed to identify activities intended to ensure appropriate conditions for the development of AI applications both in the private and public sectors in Poland, as well as in conducting scientific research.
I am an author of publications on the classification of software as a medical device, the use of AI in clinical trials and the process of research and development of drugs, and personal data processing in clinical trials, as well as co-author of international publications on digital healthcare and the protection of trade secrets.
I have been recommended in the Legal500 (Next Generation Partner) and Chambers Europe (Up and Coming) international legal rankings in Life Sciences for many years. I was also recognized as an IP Star in the field of Trademarks by the Managing IP international ranking on intellectual property law.
Before joining KRK, I worked for a law firm specializing in Life Sciences and healthcare, as well as intellectual property law.
