Monika specializes in legal advisory services for the pharmaceutical, medical device, and healthcare sectors. She advises on matters involving the registration of medicinal products, the marketing of medicinal products and medical devices, their advertising, manufacturing (including contract manufacturing), import, distribution, and compliance – including the permitted scope of interactions with healthcare professionals and patient organisations. She handles matters relating to pricing and reimbursement, attends negotiations with the Polish Ministry of Health and provides legal support during reimbursement proceedings. Her expertise covers compliance and transparency, including relationships with healthcare professionals and patients organisations. Intellectual property matters also fall within Monika’s expertise. She has drafted and negotiated numerous licence agreements regarding the rights to medicines, trademarks, know-how and copyright contracts, as well as R&D agreements. She also advises on clinical trials. Monika has a long-term experience in M&A transactions, in particular in due diligence of the companies from the pharmaceutical sector, including regulatory aspects affecting medicinal products (both for human and veterinary use), medical devices, dietary supplements, food for special nutritional purposes, and products for animal use such as feed and feed additives.
What’s more
For 15 years Monika has worked for prominent law firms, where she, among other roles, co-headed the Life Sciences practice in Central and Eastern Europe. She is an active author and commentator on topics such as clinical trials, drug reimbursement, biological medicines and their substitution, as well as public funding of non-standard treatments. Monika graduated from the Faculty of Law at the University of Warsaw. She also holds a Master’s degree in Italian Language.. She provides legal assistance in English, French, Italian and Spanish. Monika is recommended in numerous editions of Chambers & Partners and The Legal 500.
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