Legal regulation of the personal data processing in the Pharmacovigilance System in the Russian Federation

Student: Gorbik Valentina

Educational Programme: Pharmaceutical and Health Care Law (Master)

Final Grade: 9

Year of Graduation: 2024

At all stages of the life cycle of a medicinal product, it is necessary to evaluate the beneficial therapeutic effects in relation to the risks associated with its use. The maintenance of a balance between benefits and risks is a key objective of global pharmacovigilance systems. However, the rise of information and communication technologies has led to an increase in malicious attacks on information systems, resulting in potential data breaches and unlawful use. As a result, protecting personal data of individuals has become increasingly important. This study aimed to examine specific aspects of legal regulations governing the handling of personal data in pharmacovigilance systems and identify areas for improvement based on foreign practices.

Full text (added May 15, 2024)

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