Legal Regulation in Pharmaceuticals and Biotechnology is a unique master's program aimed at developing competencies related to working in the regulatory and regulatory environment of the life sciences industry. The industry includes a pharmaceutical, biotechnological block, as well as a block of medical devices. The program is of interest both from a practical point of view - in the context of cooperation with leading pharmaceutical and biotechnological structures, and in academic terms - as a step towards mastering the current direction of the development of legal research with a focus on the integration of Russian graduate students and scientists into the world academic community, intensification of publication activity and etc. The program offers the simultaneous development of two unique specializations: legal and regulatory, the demand for which in the market is steadily and constantly growing in Russia and in the world. The development of unique specializations in dynamically developing industries is expressed in the applied orientation of the program: the educational process integrates the real needs of key players in the pharmaceutical and biotechnology business, as well as the current agenda of the main regulatory bodies and scientific institutions in this area. The master's program forms a unique channel for the professional development of specialists in the field of life sciences, aimed at continuous improvement and the continuous acquisition of new knowledge. The program is focused on the formation of a solid theoretical base in the field of jurisprudence and applied industry knowledge. At the same time, in the master's program, the theory is necessarily supplemented and tested by practice. Therefore, students acquire real skills in legal and regulatory support of companies and institutions in the pharmaceutical, biotechnology, and medical sectors.

The program produces specialists who are able to carry out normative and expert tasks both independently and as part of a team based on theoretical principles, conceptual documents, or practical assignments. The graduate possesses the professional competencies necessary for the implementation of organizational and managerial activities in the form of the ability to make effective complex managerial decisions in the field of pharmaceutical law. The graduate is ready to carry out expert and consulting, analytical activities, consisting in the assessment of regulatory and law enforcement practice in the field of pharmaceutical law. The graduate possesses the skills of conducting research activities in the form of the ability to choose the best methods for conducting relevant research in the field of pharmaceutical law.

In order to increase the efficiency of the educational process and the formation of students' professional competencies corresponding to the direction 40.04.01 "Legal Studies", the master's program "Legal regulation in pharmaceuticals and biotechnologies" provides for the inclusion of a cycle of disciplines of the direction and the basic part of the cycle of disciplines of the program/specialization in the professional educational cycle ... The program includes two main blocks of academic disciplines:

1. "Pharmaceutical Law". This block is devoted to the study of the regulatory sphere of the pharmaceutical industry, including the most relevant aspects and covering areas where the existing regulation is incomplete, contradictory, or absent.

2. "Regulatory aspects of biotechnology". This block is aimed at studying the directions of regulation of the biotechnological industry, incl. taking into account the world experience and the prospects for its use for the development of the corresponding regulatory framework in the Russian Federation. The cycle of disciplines of the direction (Methodology of legal research in biotechnology and pharmaceuticals) allows you to introduce undergraduates into the course of topical problems of the studied area and the solutions proposed to date and teach undergraduates their basic research methods and skills necessary for writing coursework and final qualification work. The cycle of disciplines of the program (Pharmaceutical Law, Legal Basis of Circulation of Medical Devices, Legal Basis of Pharmaceutical Provision, Legal Regulation of Technological Development in the Pharmaceutical Industry, Research & Development in the Field of Biotechnology and Pharmaceuticals: Legal Aspects, Economics of the Pharmaceutical Industry) allow undergraduates to acquire knowledge in the main areas of legal regulation of the pharmaceutical and biotechnological sphere. The disciplines of the basic part allow undergraduates to master related issues necessary to understand approaches to the regulation of the studied area (economics, research activities), develop skills in solving practical problems. The variable part of the disciplines allows you to delve into individual problems of legal support of the studied area, the regulation of which has significant specificity. The program also offers special courses that provide the necessary scale and consistency of understanding of the studied problem: Demography and health, World experience in regulating the biotechnological sphere, AgroBioLegal. An integral part of the training on the program is a series of weekly research seminars held in the format of masterclasses, round tables, business games, etc. with the participation of invited experts representing leading research organizations, the business community, consulting companies, etc.

Выбор траектории осуществляется до 10 сентября 1 года обучения.

This degree programme of HSE University is adapted for students with special educational needs (SEN) and disabilities. Special assistive technology and teaching aids are used for collective and individual learning of students with SEN and disabilities. The specific adaptive features of the programme are listed in each subject's full syllabus and are available to students through the online Learning Management System.

All documents of the degree programme are stored electronically on this website. Curricula, calendar plans, and syllabi are developed and approved electronically in corporate information systems. Their current versions are automatically published on the website of the degree programme. Up-to-date teaching and learning guides, assessment tools, and other relevant documents are stored on the website of the degree programme in accordance with the local regulatory acts of HSE University.

I hereby confirm that the degree programme documents posted on this website are fully up-to-date.

Vice Rector Sergey Yu. Roshchin

Summary of Degree Programme 'Pharmaceutical and Healthcare Law'