Industrial pharmacy REPLICA LATINA

General expected learning outcomes The course on Pharmaceutical Technology and Legislation aims to provide the student with the basic notions regarding pharmaceutical technology, with particular reference to the main conventional pharmaceutical forms. The technological aspect is focused on the realization of medicine both at an industrial level and in the pharmacy. The course also aims to provide the main information concerning the legislation relating to the marketing authorization of a medicinal product, both at the national and European levels. Within the regulatory framework, attention is also paid to the technical standards that must be followed for the production of a medicinal product. Knowledge of the regulatory framework also concerns the legislation relating to the marketing and dispensing of medicinal products. The course will also cover the most relevant aspects relating to digital healthcare, healthcare and management information technology, pharmacoeconomic, and the ethical aspects of the pharmacist, including the regulation of the services provided in the pharmacy. As regards the practical laboratory exercises, carried out individually, the course aims to provide the student with the basic knowledge for the preparation of masterful and medicinal formulas, to carry out the checks required by the Official Pharmacopoeia, to evaluate the correct compilation of the medical prescription, to know and apply the rules connected to the act of dispensing, including the compilation of the label and the assessment of the risks related to the preparation. Specific expected learning outcomes 1. Knowledge and understanding At the end of the course, the student will have acquired the basic knowledge of pharmaceutical technology regarding the formulation, preparation, and control of the main conventional pharmaceutical forms. The student will also have learned the basics of Italian and European legislation regarding the marketing of medicines and the main regulations concerning the dispensing of medicines in pharmacies. 2. Applying knowledge and understanding At the end of the course, the student will have learned the basic knowledge of pharmaceutical technology that will allow him to monitor and control the various phases of the industrial production of medicines, follow the bureaucratic process to obtain the AIC according to the current regulatory framework. The student will be able to set up the main pharmaceutical forms, taking into account the regulatory framework and safety. You will be able to perform the calculations for the correct preparation of a masterful preparation after checking the formalisms of the medical prescription. You will have acquired the knowledge to evaluate the correctness of a medical prescription and will be able to recognize the dispensing regime in accordance with current legislation. 3. Making judgements The lessons, also carried out in an interactive way, often refer to contemporary problems in the pharmaceutical field. The laboratory exercises, carried out individually, and the numerical exercises, turn out to be all activities that, in a synergistic way, help to stimulate her critical skills in the student. The student is thus able to evaluate, having as a prerequisite a good basic preparation, the technological and regulatory aspects relating to the industrial preparation of medicines and also to their preparation as masterful preparations. 4. Communication skills During the lessons, the teacher will solicit debate and comparison to stimulate in the student good reasoning and communication skills that will be useful in the workplace, both in the case of inclusion in work groups in which he will have to deal with other colleagues and in the case he is entrusted with the task of controlling company activities carried out by others which must be coordinated by him. Good communication, together with good technical knowledge, will also be essential in the case of practicing the profession of pharmacist in which contact with the public plays a fundamental role in terms of the possibility of providing patients with highly professional advice and information (e.g. how to use the medicine correctly, how to avoid interactions with other active ingredients). 5. Learning skills The student, also thanks to the help of the recommended texts and websites, will be able to enter the world of work, both in the industrial sector and in the pharmacy sector. This will be possible because the student will have become aware, during the course of the lessons and during the preparation for the exam, of how essential continuous updating is for professional purposes, both from the point of view of new technologies and from a regulatory point of view, a reality which are always evolving.