PHARMACEUTICAL TECHNOLOGY AND LEGISLATION

Course objectives

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.

Channel 1
PIETRO MATRICARDI Lecturers' profile

Program - Frequency - Exams

Course program
Introduction (2 ore) European Directives. Definition and classification of medicines. AIC (autorizzazione immissione in commercio(. Patents. Generics. Good Manufactoring Procedures (Norme di Buona Fabbricazione) and Good Manufactoring Procedures in Farmacia (NBP). The organization of the pharmaceutical service. The medical recipe: ricetta ripetibile (RR), ricetta non ripetibile (RNR), ricetta limitativa. (12 ore) Medicinali con AIC, galenici, SOP e OTC. Metodologia di formazione del prezzo delle preparazioni magistrali: la nuova Tariffa Nazionale dei Medicinali. Regime di autoregolamentazione per i multipli. (6 ore) Le Tabelle della Farmacopea. La Tabella n.2. La Tabella n.3: i “veleni” e loro dispensazione. La Tabella n.4. La Tabella n.5. La Tabella n. 6. La Tabella n.7: Disciplina relativa alla produzione, acquisto e dispensazione di sostanze stupefacenti e psicotrope. Il DPR 309/90 e suoi aggiornamenti. La terapia del dolore. Ricetta medica a ricalco (RMR). Progetto pilota e dispensazione della cannabis. (12 ore) Normativa relativa alle sostanze il cui impiego e' considerato doping. (2 ore) Pharmaceutical dosage forms: classification. Powders: features and analysis. Tablets. Capsules. Suppository. Hydroalcoholic solutions. Ophtalmic reparations. (16 ore) Interfacial phoenomena. Emulsions and Suspensions. Solutions. Rheology. Expiry date: t10%. (10 ore) Tests and procedures provided by F.U. for the pharmaceutical dosage forms. (4 ore) Lab preparations of the most common dosage forms. Numerical excercises. (40 ore)
Prerequisites
Necessary: Basic knowledge of Inorganic and Organic Chemistry, Mathematic, Physic, Medicinal Chemistry. Important: Farmacology and Toxicology Useful: Medicinal Chemistry Analysis
Books
1. P.Colombo, F.Alhaique, C.Caramella, B.Conti A.Gazzaniga, E.Vidale, "Principi di tecnologia farmaceutica", Casa Editrice Ambrosiana, 2015. 2. Aulton, “Tecnologie Farmaceutiche - Progettazione e allestimento dei medicinali”, Edra,Italia, 2015. 3. P.Minghetti, "Legislazione Farmaceutica", Casa Editrice Ambrosiana, ultima edizione. 4. Nicoletta Loliscio, “La Farmacia. Un campo minato. Il manuale del farmacista”, Società editrice Esculapio, 2021. 5. Fotocopie degli appunti di lezione e materiale messo a disposizione sul sito del docente.
Teaching mode
The course of Pharmaceutical Technology and Law is based on lessons given in class by the teacher (8 CFU) and on individual practical laboratory experiences and numerical exercises (2 CFU) The lessons are carried out also by continuous interactions with the students, which are stimulated with questions about the current topic. Being the course almost at the end of their studies (2nd semester of the fourth year), each student is often invited to review the information acquired during the previous courses in order to really understand the topics of pharmaceutical technology. The teacher very often stimulates the students to express their opinions concerning some topics of the course which belong to the everyday life experience or with social-ethical aspects (e.g., generics, doping, pain relief law, cannabis uses, etc.). Furthermore, during the course, some seminars of experts in regulatory affairs are also prosed (e.g. AIFA and Pharmaceutical Industry members). In addition, on the e-learning website, books of pharmaceutical technology are listed, together with some specific official website addresses, that are fundamental for a correct approach to the understanding of the topics discussed during the lessons, especially for the regulatory affairs. Lesson attendance is not mandatory but deeply suggested for a better and easier understanding of the topics of the course. The attendance to the practical laboratory experiences is mandatory.
Frequency
Lesson attendance is not mandatory but deeply suggested for a better and easier understanding of the topics of the course. The attendance to the practical laboratory experiences is mandatory
Exam mode
For the evaluation of the students there are six session exams per year: two in summer, after the end of the lessons, two in autumn and two in winter. The exam is divided in two parts: a preliminary written examination (which lasts 90 minutes) followed by an oral exam. The written exam contains four open questions: - in the first question a medical prescription for a galenic preparation is proposed and the student must comment in detail the legal aspects, including the prescription law, the duties of the physician and those of the pharmacist. - two questions deal with numerical calculations concerning subjects discussed during the lessons (e.g., calculations for the preparation of isotonic solutions, calculations for the shelf-life of market drug, calculations for the preparation of hydroalcoholic solutions, calculations for the preparation of dosage forms, etc.) - the last question asks the student to briefly describe, in correct Italian language, one of the topics of the course, concerning pharmaceutical technology or pharmaceutical law. The oral exam has no exact duration, depending obviously on the many variables. The student is asked to comment and to explain the errors present in the written composition, if any. Questions, in pharmaceutical technology and law, are also proposed. One question on the practical laboratory experiences carried out during the course is also proposed. The capability to appropriately express the topics of the course, the way of thinking, that mainly infer from the execution of the written test, the capability to independently make judgements represent the parameters taken into account in order to give an evaluation of the overall exam. In order to pass the exam with the minimum the student is asked to show a sufficient competence of the course topics and sufficient speech skills together with a sufficient capability to independently make judgements. To reach 30 cum laude the student must demonstrate a particularly excellent preparation in all topics of the course, showing an understanding beyond the factual knowledge. It has to be underlined that, being the course strictly connected with the future professional life, the knowledge acquired during the mandatory internship spent for six months (full time) in the Pharmacy, represents the best complement for the final preparation of the exam.
Bibliography
1. M. Cini, P Rampinelli, “Principi di legislazione farmaceutica”, Edizioni Minerva Medica, 2019. 2. F.U. XII Edizione, Istituto Poligrafico dello Stato, e successivi aggiornamenti. 3. "Manuale delle preparazioni galeniche", IV ediz., F. Bettiol, Tecniche Nuove ed., 2017. 4. G.C.Ceschel, L.Fabris, E.Lencioni, S.Rigamonti, “Impianti per l'industria farmaceutica", Società Editrice Esculapio,1996. 5. http://www.ministerosalute.it 6. https://www.aifa.gov.it/ 7. http://www.ema.europa.eu 8. https://ec.europa.eu/health/documents/eudralex_it 9. http://www.galenotech.org 10. Aggiornamenti normativi presenti in G.U.
Lesson mode
The course of Pharmaceutical Technology and Law is based on lessons given in class by the teacher (8 CFU) and on individual practical laboratory experiences and numerical exercises (2 CFU) The lessons are carried out also by continuous interactions with the students, which are stimulated with questions about the current topic. Being the course almost at the end of their studies (2nd semester of the fourth year), each student is often invited to review the information acquired during the previous courses in order to really understand the topics of pharmaceutical technology. The teacher very often stimulates the students to express their opinions concerning some topics of the course which belong to the everyday life experience or with social-ethical aspects (e.g., generics, doping, pain relief law, cannabis uses, etc.). Furthermore, during the course, some seminars of experts in regulatory affairs are also prosed (e.g. AIFA and Pharmaceutical Industry members). In addition, on the e-learning website, books of pharmaceutical technology are listed, together with some specific official website addresses, that are fundamental for a correct approach to the understanding of the topics discussed during the lessons, especially for the regulatory affairs. Lesson attendance is not mandatory but deeply suggested for a better and easier understanding of the topics of the course. The attendance to the practical laboratory experiences is mandatory.
Channel 2
PATRIZIA PAOLICELLI Lecturers' profile

Program - Frequency - Exams

Course program
Introduction (2 hours) European Directives. Definition and classification of medicines. AIC (autorizzazione immissione in commercio). Patents. Generics. Good Manufactoring Procedures (Norme di Buona Fabbricazione) and Good Manufactoring Procedures in Farmacia (NBP). The organization of the pharmaceutical service. The medical recipe: ricetta ripetibile (RR), ricetta non ripetibile (RNR), ricetta limitativa. (12 hours) Medicinali con AIC, galenici, SOP e OTC. Metodologia di formazione del prezzo delle preparazioni magistrali: la nuova Tariffa Nazionale dei Medicinali. Regime di autoregolamentazione per i multipli. (6 hours) Le Tabelle della Farmacopea. La Tabella n.2. La Tabella n.3: i “veleni” e loro dispensazione. La Tabella n.4. La Tabella n.5. La Tabella n. 6. La Tabella n.7: Disciplina relativa alla produzione, acquisto e dispensazione di sostanze stupefacenti e psicotrope. Il DPR 309/90 e suoi aggiornamenti. La terapia del dolore. Ricetta medica a ricalco (RMR). Progetto pilota e dispensazione della cannabis. (12 hours) Normativa relativa alle sostanze il cui impiego e' considerato doping. (2 hours) Pharmaceutical dosage forms: classification. Powders: features and analysis. Tablets. Capsules. Suppository. Hydroalcoholic solutions. Ophtalmic reparations. (16 hours) Interfacial phoenomena. Emulsions and Suspensions. Solutions. Rheology. Expiry date: t10%. (10 hours) Tests and procedures provided by F.U. for the pharmaceutical dosage forms. (4 hours) Lab preparations of the most common dosage forms. Numerical excercises. (40 hours)
Prerequisites
Necessary: Basic knowledge of Inorganic and Organic Chemistry, Mathematic, Physic, Medicinal Chemistry. Important: Farmacology and Toxicology Useful: Medicinal Chemistry Analysis
Books
1) Aulton ME, Tylor KMG. Tecnologie farmaceutiche. Progettazione e allestimento di medicinali 2) Colombo P et al. Principi di Tecnologia farmaceutica 3) Principi di Tecnica Farmaceutica" M. Amorosa, VI ed. 2021, Piccin 4) Farmacopee Ufficiali (Edizioni correnti) 5) Fabris L, Rigamonti A. La fabbricazione industriale dei medicinali 6) Minghetti P. Legislazione Farmaceutica. Casa editrice Ambrosiana. X edizione 7 ) Barberini G., Casettari L. Legislazione Farmaceutica nella pratica professionale. Piccin
Frequency
Lesson attendance is not mandatory but deeply recommended for a better and easier understanding of the topics of the course. The attendance to the practical laboratory experiences is mandatory.
Exam mode
For the evaluation of the students there are six session exams per year: two in summer, after the end of the lessons, two in autumn and two in winter. The exam is divided in two parts: a preliminary written examination (which lasts 90 minutes) followed by an oral exam. The written exam contains three open questions: - in the first question a medical prescription for a galenic preparation is proposed and the student must comment in detail the legal aspects, including the prescription law, the duties of the physician and those of the pharmacist. - two questions deal with numerical calculations concerning subjects discussed during the lessons (e.g., calculations for the preparation of isotonic solutions, calculations for the shelf-life of market drug, calculations for the preparation of hydroalcoholic solutions, calculations for the preparation of dosage forms, etc.) - the last question asks the student to briefly describe, in correct Italian language, one of the topics of the course, concerning pharmaceutical technology or pharmaceutical law. The oral exam has no exact duration, depending obviously on the many variables. The student is asked to comment and to explain the errors present in the written composition, if any. Questions, in pharmaceutical technology and law, are also proposed. One question on the practical laboratory experiences carried out during the course is also proposed. The capability to appropriately express the topics of the course, the way of thinking, that mainly infer from the execution of the written test, the capability to independently make judgements represent the parameters taken into account in order to give an evaluation of the overall exam. In order to pass the exam with the minimum the student is asked to show a sufficient competence of the course topics and sufficient speech skills together with a sufficient capability to independently make judgements. To reach 30 cum laude the student must demonstrate a particularly excellent preparation in all topics of the course, showing an understanding beyond the factual knowledge.
Lesson mode
The course of Pharmaceutical Technology and Law is based on lessons given in class by the teacher (8 CFU) and on individual practical laboratory experiences and numerical exercises (2 CFU) The lessons are carried out also by continuous interactions with the students, which are stimulated with questions about the current topic. Being the course almost at the end of their studies (2nd semester of the fourth year), each student is often invited to review the information acquired during the previous courses in order to really understand the topics of pharmaceutical technology. The teacher very often stimulates the students to express their opinions concerning some topics of the course which belong to the everyday life experience or with social-ethical aspects (e.g., generics, doping, pain relief law, cannabis uses, etc.). Furthermore, during the course, some seminars of experts in regulatory affairs are also prosed (e.g. AIFA and Pharmaceutical Industry members). In addition, on the e-learning website, books of pharmaceutical technology are listed, together with some specific official website addresses, that are fundamental for a correct approach to the understanding of the topics discussed during the lessons, especially for the regulatory affairs.
  • Lesson code1022903
  • Academic year2024/2025
  • CourseIndustrial pharmacy
  • CurriculumSingle curriculum
  • Year4th year
  • Semester2nd semester
  • SSDCHIM/09
  • CFU10
  • Subject areaDiscipline tecnologiche normative e economico-aziendali