Monika specialises in the pharmaceutical and healthcare law. She provides counselling to the pharmaceutical and medical devices sector since 1999. She advises first of all companies from the pharmaceutical, medical devices and food sectors (producers, their affiliates and distributors), as well as investment funds (including private equity) and other law firms requiring expertise in reimbursement, pharmaceutical and medical devices laws and similar sector regulations.
Monika advises clients in relations to marketing authorisations, regulatory data protection, distribution of medicinal products and medical devices, promotion and advertising, manufacturing (including contract manufacturing) and importation. She also advises on compliance, including relationships with healthcare professionals, patients organisations and sponsorships. She conducted compliance audits and drafted compliance policies for companies from the pharmaceutical and medical devices sector; she also assisted clients in criminal proceedings involving compliance issues. Monika also advises on matters relating to reimbursement of medicinal products and medical devices She took part in price negotiations with the Economic Commission and she drafted risk-sharing instruments (RSS). Monika also advises on intellectual property matters, in particular in contracts on purchase or licensing rights to medicines (licenses to use registration dossiers) in copyright contracts, and on trademarks. Monika drafts and reviews draft R&D agreements concerning medicines and medical devices.
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.
For most of her professional life Monika was working in big law firms. For 12 years she was a member of the Lifesciences team at Wierzbowski Eversheds. For 3 years, she was a Partner at CMS Cameron McKenna, where she headed the Lifesciences team and the co-head of the Lifesciences practice in CEE. Monika has a law master degree and a Italian Language master degree, both obtained at Warsaw University. She provides legal assistance in English, French, Italian and Spanish. Ranked in numerous editions in Chambers & Partners, and in Legal 500 legal ranking.
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Bar admission: 2002
Languages: English, French, Italian, Spanish and Russian
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