Discussion of the master “Industrial Pharmacy” in the University named after I. Sechenov
On May 23, 2018 at the University named after I. Sechenov a seminar devoted to the expert discussion of the projects of modular basic professional educational programs on Federal Learning Standard “Industrial Pharmacy” academic backgrounds of “Management of the development of medicines” and “Quality assurance of medicines / Authorized person for quality” and an additional professional program “Study of the stability of medicines”, developed within the framework of the project” Development of a model for a multilevel advanced training system moat to ensure long-term development of the Russian pharmaceutical industry “, initiated by the Ministry of Education and Science of the Russian Federation was held.
The event was attended by representatives of industry`s competence centers established on the basis of leading universities – partners of the Sechenov University, scientific organizations, manufacturers of medicines, as well as a representative of the FSI “SID & GP”, Head of the Department of scientific and methodological work and training, Madina Sottaeva .
In the decree of the President of Russia “On national goals and strategic objectives of the development of the Russian Federation for the period up to 2024”, it was noted the aim of national projects in the spheres of education and science, such as the introduction of adaptive, practice-oriented and flexible educational programs, that will enable students to acquire new competencies and professional skills, as well as the formation of a system of continuous updating of their professional knowledge by colleagues and the acquisition of new professional skills, including possession of competencies in the field of the digital economy, which will push the pharmaceutical industry to the next level. The pharmaceutical industry of the 21st century is marked by science intensity, the use of a scientific approach, interdisciplinary, the use of risk management methods, knowledge management, and ever-increasing regulation by the state.
The sphere of education was also changed: new branches of knowledge, new educational programs, generally Master’s ones, in particular in the 70s of the last century were marked by the creation of such a direction of education as “Industrial Pharmacy”. In Russia, this sphere of training was introduced by the order of the Ministry of Education and Science of Russia in December 2016. In July 2017, the Federal State Educational Standard of higher education was approved – the Master’s Degree in the sphere of “Industrial Pharmacy”. The Master’s degree in Industrial Pharmacy provides an opportunity to expand the necessary competencies for those professionals who have not received a pharmaceutical education.
Within the framework of the discussed projects, the model of the Personnel Training System for the perspective development of the pharmaceutical industry was presented, which involves the creation of interdisciplinary educational programs and the bringing of interdisciplinary interaction through the network of these programs. A model of professional activity in the pharmaceutical industry was also presented. The model reflects activities that involve the accreditation / qualifying examination / certification of an employee. Based on the requirements established for certain activities, it is important to understand what programs students need, and in what format it is necessary for the industry.
Two developed projects of the basic professional educational programs in the sphere of training for the Master in “Industrial Pharmacy”, discipline “Management of the development of medicines” and “Ensuring the quality of medicines” were presented. The general parameters for the disciplines of the Master’s program are the following: the volume of the program is 120 credit points, the duration of the training program is 2 years, full-time. This educational standard allows usage of distance learning technologies and e-learning in the course of training.
The pdiscipline “Management of the development of medicines” was developed on the basis of the professional standard “Specialist in industrial pharmacy in the field of drug research”, the discipline “Ensuring the quality of medicines”, which is supposed to include the training of authorized persons – on the basis of the professional standard “Specialist in Industrial Pharmacy in the field of quality assurance of medicines”.
For obtaining of master’s, students are offered modules common to two disciplines:
· Design, statistics and ethics of medico-pharmaceutical research and life cycle management of medicines
· Project and innovative management in pharmacy and medicine
· Information and Communication Module
· General and clinical pharmacology
· Toxicology and preclinical development of drugs
· Drug management and good practices
For the “Drug Development Management” discipline additional modules:
· Clinical Development Management (Clinical Research and GCP Management, Formulation and Evaluation of Medicinal Forms, Biopharmacy, Development of a Registration Dossier)
For the discipline “Quality assurance of medicines” additional modules:
· Scientific Module (Physiology, Biochemistry, Microbiology, Medical Physics)
· Pharmaceutical technology, drug development and production
· Good Manufacturing Practice (GMP)
· Pharmaceutical chemistry, pharmacognosy and biopharmacy
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- The issues of the legal and regulatory framework of pharmaceutical activities in Russian and the EAEU were discussed by participants of the VI All-Russia Congress
- The experts of FSI «SID & GP» took part in the meeting of Indian manufacturers and suppliers of the pharmaceutical industry with Russian colleagues
- «Requirements and Application of GMP Rules to Manufacture of APIs» – an open expert-advisory workshop
- Russian drugs penetration to the key segments of the pharmaceutical market rose in the 1st half of 2018