Pharmacy

General objectives The lessons and seminar activities contribute to the development of the following skills: - know the problems of formulation, production and control of biotechnological medicines, biosimilars and advanced therapies, with particular attention to the relevant national and international standards; - know the formulation, production and control issues of medical devices with particular attention to the relevant national and international standards; - evaluate the use of the categories presented during the course according to the principles of quality, safety and economic sustainability. Specific objectives, upon completion of the course Knowledge and understanding of - basic elements related to the formulation, preparation, classification and control of biotechnological and biosimilar medicinal products; - basic elements related to the formulation of advanced therapies; - national and international regulatory aspects of the formulation, preparation, classification, control, marketing and supervision of biotechnological medicines, biosimilars and medical devices. Ability to apply knowledge and understanding: - to follow the main stages of production control of biotechnological and biosimilar medicinal products, with particular regard to regulatory problems and their safety; - to follow the main phases of the development of advanced therapies, with particular regard to regulatory problems and their safety; - to be able to apply the knowledge of the European Directives on Medical Devices and Medical Devices for in Vitro Diagnostics, to the regulatory and qualitative activity within a supplier or manufacturer of one of these Devices, but also at the base of the working activity of Entities that have to evaluate the latter. - to develop knowledge and skills suitable for a correct evaluation, selection, information and use in compliance with current legislation and the clinical needs of patients of the products in question. Judgment autonomy The lessons and seminar activities allow the student to: - evaluate the managerial, technological and practical aspects related to the preparation, production, control, distribution and sale of biotechnological medicines, biosimilars and medical devices; - identify and evaluate the risks related to the control of advanced therapy, biotechnological medicines, biosimilars and medical devices; Communication skills During the course there will be moments of comparison and debate, coordinated by the teacher, aimed at verifying the ability to communicate/transmit what the student has learned. Furthermore, these moments are fundamental for the development of critical evaluation and reasoning skills by the student which will allow him to report, in the exercise of the profession, information, advice and solutions to specialist and non-specialist interlocutors. Self-learning ability The tools provided during the course allow the student to enter the world of work thanks to the set of knowledge to deal with both the professional practice in pharmacy and the sequence of the production and control process of biotechnological medicines, biosimilars and medical devices. Knowledge of the legislation, which is constantly evolving, and the socio-economic aspects represent an indispensable step in the training process of the student in Pharmacy. The knowledge acquired during the course therefore constitutes essential and strongly characterizing training elements for the exercise of the profession of pharmacist in the various working environments.