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General Information
Selected experience
Ratings and Awards
Academic and education activities
News and publications
Karina Kolobova
Counsel, Head of Practice
Languages
Russian, English
Karina specializes in the legal governance of the healthcare sector, addressing complex regulatory and commercial matters, antitrust regulations within the industry, and regulatory concerns associated with data management and digital innovation, particularly within the healthcare domain.

Karina has extensive experience in leading initiatives for pharmaceutical entities, medical device enterprises, and high-tech firms, including top-tier players in the digital health industry, supporting substantial asset deal transactions in the pharma market, and projects establishing special legal frameworks (regulatory sandboxes, innovative scientific and technological hubs).

Under Karina's guidance, the practice evolves in areas such as consulting on proper GMP and GDP services, complicated aspects of organizing and conducting clinical trials, technology transfers, setting up medicinal product manufacturing in international markets, and implementing complex commercial interaction models among pharmaceutical market stakeholders.

Karina is actively engaged in legislative initiatives in the realm of digital healthcare and medical data. She is a founding member and visionary leader of the Life Sciences Legal Club (a consortium of in-house lawyers from the pharmaceutical and medical device sectors). Annually, Karina serves as a legal authority invited by the Central Research Institute for Organization and Informatization of Healthcare (a federal state-funded institution under the Russian Ministry of Health) at events aimed at enhancing the professional expertise of industry personnel in digital healthcare.

Selected Experience
Karina advised:
a project to bring a coronavirus vaccine to foreign markets;
a leading pharmaceutical company on GDP compliance advice and structuring contracts with 3PL providers to ensure product quality;
a Russian medical devices manufacturer during control and supervisory activities related to medical device quality;
achievements
Ratings and Awards
Karina is endorsed by Russian ratings, including: Pravo-300, Kommersant and Rossiyskaya Gazeta.

Pravo-300 in the nominations: Data Protection, Compliance, Pharmaceuticals and Healthcare (Medicine and Healthcare), Pharmaceuticals and Healthcare (Pharmaceuticals), Digital Economy

Kommersant in the nominations: Digital Economy / FinTech, Healthcare and Pharmaceuticals, Data Protection

Rossiyskaya Gazeta in the nomination: Healthcare
Academic and education activities
Karina is a tenured lecturer at the School of Digital Law and Bio-Law at the National Research University Higher School of Economics, an expert at the Center for Pharmaceutical and Biotechnology Research at the same university, and a visiting lecturer at other prominent Russian universities, teaching subjects related to the pharmaceutical industry and medical device regulation. At the National Research University Higher School of Economics, within the “Pharmaceutical Law and Healthcare” Master's program, Karina leads a course on R&D in healthcare and supervises numerous master's theses.

Karina has designed a continuous training program in pharmaceutical law for the Moscow Digital School platform.

Karina serves as a lecturer at the Statute Law School, part of the Codex Consortium.

Karina regularly contributes as an expert to student legal contests, including the Kutafin Legal Cup.
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