Currently, there is a rapid growth of domestic manufacturers of medicines, which determines the need for a highly qualified R&D team with specialized competencies in the field of pharmaceutical development. The analysis of regulatory documents regulating the field of industrial pharmacy, master’s degree educational programs implemented in the territory of the Russian Federation, and the opinions of current employees of an organization engaged in pharmaceutical development revealed the need to develop and justify an approach to the training and development of specialists in this field. OBJECTIVE: to substantiate an approach to the education and development of specialists for pharmaceutical development, based on best practices and specialized knowledge and skills of employees of R&D departments. MATERIALS AND METHODS: regulatory documents and professional standards in the field of industrial pharmacy, recommendations for the design of educational programs, the results of a survey of employees of the company developing reproduced medicines were studied using the sociological method (questionnaire), structural–logical, comparative and correlation analysis. RESULTS AND DISCUSSIONS: during the study, aspects of training and development of employees of R&D departments were analyzed on the basis of scientific papers, professional standards of specialists in industrial pharmacy, methodological recommendations for the development of educational programs and the experience of the directorate of the organization developing reproduced medicines. Based on this, a survey was formed, which includes 111 questions formed into 4 independent blocks: determining the specifics of staff training, the relevance of additional education for pharmaceutical development specialists, the importance of general knowledge and the importance of specific knowledge depending on the department of work of employees. Individual questions were evaluated using the Likert scale, placing the significance of the answers in accordance with the scores. According to the results of the survey, the areas of general and specific knowledge and skills were identified and ranked. Based on professional standards and survey results, the necessary specialized competencies of R&D specialists are substantiated and formulated. The conducted study allowed us to propose an approach to the formation of an educational program for additional professional education of specialists in the field of pharmaceutical development. Conclusion: the implementation of the proposed approach to the formation of an educational program of additional training with its subsequent implementation at the master’s level is expected to provide training for specialists in the field of pharmaceutical development who will be able to effectively solve the tasks of developing effective, safe and high-quality medicines, implementing a drug safety strategy in the territory of the Russian Federation.