Karina Kolobova
Senior Associate
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).
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.
Karina's previous experience includes positions at major Russian law firms and a large multinational pharmaceutical corporation.
achievements
Ratings and Awards
Karina is recognized as a recommended lawyer in the Pravo.300 ranking within the Pharmaceuticals and Healthcare (band 1) category.
Karina has been honored as the most influential expert within the GxP community in 2021.
In 2023, Karina was recognized in band 1 in the Healthcare category of the Rossiyskaya Gazeta's legal professionals ranking.
Karina has been honored as the most influential expert within the GxP community in 2021.
In 2023, Karina was recognized in band 1 in the Healthcare category of the Rossiyskaya Gazeta's legal professionals ranking.
Education
Karina graduated with honors from the Faculty of Law at the National Research University Higher School of Economics and holds a Master's degree in Legal Regulation in Pharmaceuticals and Biotechnology.
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.
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.
projects
Selected project experience
Facilitated the expansion of a coronavirus vaccine into international markets.
Provided comprehensive legal support for the initiation of commercial operations in the Russian Federation by an international pharmaceutical manufacturer.
Assisted international pharmaceutical companies in their offices with complex regulatory and commercial matters integral to their ongoing business operations (experience with 6 companies).
Aided a pharmaceutical company in substantial transactions involving the transfer of drug portfolios, including comprehensive negotiation support. One notable transaction was the assistance provided to Alium (part of Binnopharm Group, an AFK Sistema asset) in acquiring two antibacterial drugs from one of the world's largest pharmaceutical corporations, Dr. Reddy's Laboratories, in a deal exceeding 2 billion RUB. The transaction was structured as an asset deal and involved the transfer of rights to the acquired pharmaceutical products. As a result, the client bolstered their position in the antibiotics market, while Dr. Reddy's focused its resources on its core therapeutic medications.
Developed commercial policies for a pharmaceutical company, as well as crafting distributor agreements in alignment with those policies.
Provided consultancy services to leading pharmaceutical companies on complex regulatory matters related to the conduct of clinical studies, including the development of compliant organizational structures and contractual frameworks for clinical research, advising on the feasibility and procedures for patient compensation within clinical trials.
Offered comprehensive support to a company in the digital healthcare field participating in regulatory sandboxes.
Authored a universal comprehensive manual for the implementation of medical technology transfers, designed for organizations engaged in healthcare research and development. This manual provides exhaustive information to give its users a thorough understanding of the legal nuances of transferring medical technologies in Russia and the CIS, detailing specific regulatory requirements and the contractual interactions involved in the transfer process.
Played a leading role in a working group advocating for amendments to the regulation of Software as a Medical Device (SaMD), contributing to the accompanying legislative reforms and guidance issued by the Russian health regulatory authority, Roszdravnadzor.
Provided comprehensive legal support for the initiation of commercial operations in the Russian Federation by an international pharmaceutical manufacturer.
Assisted international pharmaceutical companies in their offices with complex regulatory and commercial matters integral to their ongoing business operations (experience with 6 companies).
Aided a pharmaceutical company in substantial transactions involving the transfer of drug portfolios, including comprehensive negotiation support. One notable transaction was the assistance provided to Alium (part of Binnopharm Group, an AFK Sistema asset) in acquiring two antibacterial drugs from one of the world's largest pharmaceutical corporations, Dr. Reddy's Laboratories, in a deal exceeding 2 billion RUB. The transaction was structured as an asset deal and involved the transfer of rights to the acquired pharmaceutical products. As a result, the client bolstered their position in the antibiotics market, while Dr. Reddy's focused its resources on its core therapeutic medications.
Developed commercial policies for a pharmaceutical company, as well as crafting distributor agreements in alignment with those policies.
Provided consultancy services to leading pharmaceutical companies on complex regulatory matters related to the conduct of clinical studies, including the development of compliant organizational structures and contractual frameworks for clinical research, advising on the feasibility and procedures for patient compensation within clinical trials.
Offered comprehensive support to a company in the digital healthcare field participating in regulatory sandboxes.
Authored a universal comprehensive manual for the implementation of medical technology transfers, designed for organizations engaged in healthcare research and development. This manual provides exhaustive information to give its users a thorough understanding of the legal nuances of transferring medical technologies in Russia and the CIS, detailing specific regulatory requirements and the contractual interactions involved in the transfer process.
Played a leading role in a working group advocating for amendments to the regulation of Software as a Medical Device (SaMD), contributing to the accompanying legislative reforms and guidance issued by the Russian health regulatory authority, Roszdravnadzor.
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