Ateneo - UPO

PART 1 - The course introduces national and European legislative systems. It covers the fundamentals of legislation regarding the pharmaceutical sector and the distribution of medicines for human and veterinary use, as well as “parafarmaco”; regulatory aspects concerning pharmacy classification and the pharmacist's professional liability are also addressed. An overview is provided regarding homeopathic products, medical devices, and biocides. The Marketing authorization and the protection of intellectual property are briefly addressed.
PART 2 - Preparatory lessons and practical laboratory exercises: preparation, price composition, labeling, and quality control of magistral and officinal galenic formulations. Use of software for the management of professional activity.

Minghetti P., Legislazione Farmaceutica, C.E.A., Milano. - Farmacopea Ufficiale Italiana in force, IPZS. - European Pharmacopoeia in force, EDQM. - Tortorella V., et al., Tirocinio professionale in farmacia, Ed. Merqurio, Napoli. - Cipollone R., Dizionario giuridico della farmacia, Editoriale Giornaleidea. - D’Agostini G., Manuale del cosmetologo, Tecniche Nuove, Milano. - Pacenti G.C., et al., La farmacia dei servizi, Tecniche nuove, Milano. - Lombardo Q., et al., La nuova farmacia del decreto Monti, Tecniche nuove, Milano. - Loliscio N., La farmacia: un campo minato. 2026. Ed. Esculapio. - Morel S., Grosa G., Preparazioni galeniche Esercizi di tariffazione secondo la nuova TNM, Ed. Libreria Rescalli, Novara Caliceti P. Tecnologia Farmaceutica. Casa Editrice Ambrosiana. 2025. Also ebook. - Aulton ME et al. Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali. Edra. 2015. - Colombo P et al. Principi di tecnologia farmaceutica. Casa Editrice Ambrosiana. 2015. - Amorosa M. Principi di tecnica farmaceutica. Sesta edizione, Ed. Piccin. 2021. - Ansel HC et al. Principi di calcolo farmaceutico. Quindicesima edizione. Edra. 2017. Also ebook. - Frongia M, Casettari L. Il galenista e il laboratorio. Edra. 2018. Also ebook. - Baratta et al. Manuale di galenica a uso umano e veterinario. Zanichelli. 2019. Also ebook. - Bettiol F. Manuale delle preparazioni galeniche: arte del preparare e attrezzature per oltre 1500 formulazioni magistrali, officinali, fitoterapiche e omeopatiche. Tecniche nuove. 2022. - Bettiol F et al. Manuale delle preparazioni veterinarie: normativa, REV, gestione dei medicinali, formulazioni galeniche tradizionali e innovative in campo veterinario. Tecniche nuove. 2025. - Bettiol F, Cecchi M. Manuale delle preparazioni cosmetiche e dermatologiche: oltre 500 formulazioni di cosmetici, fitocosmetici, cosmeceutici e medicinali a uso topico. Tecniche nuove. 2018. - Fabris L, Rigamonti S. La fabbricazione industriale dei medicinali. Esculapio. 2008. - Buone pratiche di fabbricazione: linee guida AFI. Tecniche nuove. 2005.

PART 1 - The first part of the course aims to provide students the knowledge and the understanding of the national and supranational legal framework governing the fundamentals of pharmaceutical legislation, including industrial production, marketing authorization, classification, and dispensing to the public of medicinal products for human and veterinary use.
PART 2 - The second part of the course aims to provide the students with theoretical and practical information about preparation methods, price determination, labeling, and quality control of magistral and officinal galenic preparations, according to the pharmacopoeia requirements. Particular attention is dedicated to describing the technological characteristics of the immediate-release dosage forms usually prepared in pharmacies and the pharmaceutical industry.

We recommend a good knowledge of previous year courses, in particular Pharmaceutical Chemistry, Pharmacology, and Pharmaceutical Technology.

PART 1 - The course is throughout the year with lectures lessons.
The teachings will be delivered in such a way as to encourage students to take an active role, helping to stimulate a critical spirit, autonomy and involving them in learning processes.
PART 2 - The mandatory practical exercises are carried out individually in the laboratory. Some information is provided about using specific informatics media to manage the pharmacist’s professional activity, and the correlated individual exercises are carried out in the informatics laboratory. 3 CFU are dedicated to all laboratory exercises.

External specialists can supplement lessons with seminars.
The frequency of the preparatory lessons for the laboratory and the practical laboratory exercises is mandatory and certified by the teachers. It is not allowed to record, videos or photograph the lectures, the preparatory lessons for the laboratory and the practical exercises. Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities. Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects. Then, they must contact the lecturer regarding specific exam procedures and instructional aspects, at least 10 days in advance as stipulated by University regulations.

PART 1 - Oral with questions throughout the program, according to the schedule established annually. The level of difficulty of the questions corresponds to the program and the reference texts. During the oral exam the student is asked some questions on the main topics covered during the course with the dual purpose of verifying the level of knowledge and understanding of the course contents and to evaluate the autonomy of judgment, the learning ability and the communication skills. To pass the exam, the student must demonstrate knowledge and understanding at least of the fundamental concepts and the most important results relating to them. A wider knowledge and understanding of the contents of the program, which in particular allows the student to establish the connections between topics covered in different chapters of the program and greater autonomy in identifying errors and their correction, lead to an evaluation above sufficiency; to achieve a high grade, the student must be able to independently use their knowledge and understanding of the teaching contents to face an in-depth discussion on critical aspects relating to the topics covered and to be able to present their conclusions in a clear and logical. The use of appropriate language and rigorous terminology is recommended.
PART 2 - Practical laboratory exercises are preceded by an in itinere written test on the main notions covered during the lessons preparatory to the laboratory. The student can perform the practical part of the laboratory only in case of sufficient results (≥ 18/30). Otherwise, the student can perform the practical part of the laboratory only after putting right the theoretical gaps. During the practical laboratory, the ability to apply the knowledge acquired is evaluated, considering the accurate presentation of the pharmaceutical preparation, the correct expedition of a medical recipe, and the composition of the technical report about the quality control of the officinal products students prepare. Interim evaluations are considered valid for the exam if the grade, expressed in thirtieths, is greater than/equal to eighteen. The overall grade, expressed in thirtieths, is calculated from the average, weighted on the number of CFU, of the grades obtained in the written and in itinere written tests, and the practical exercises.

PART 1 - Basic definitions: Dlvo 219/06, F.U. Italian Pharmacopoeia. European Pharmacopoeia. International Pharmacopoeia. USP-NF. Notices about Italian, international and European legislation. GMP and CQ. NBP. Marketing authorization for medicinal products. GDP. CTD. AIFA and EMA websites. Ministry of Health, Italian Medicines Agency, Local Health Authorities. Classification of Pharmacies. Distribution of pharmacies on the territory. Health professions. Professional associations. Licensed to practice. Responsibility of the pharmacist. Pharmaceutical services. Administrative. Pharmacist ethics code Supervision of pharmaceutical services. Inspections at the pharmacy. Texts, registers and documents required. Prescription of medicinal products for human use (Dlgs 219/2006). The electronic prescription. Narcotic drugs (DPR309/90 and successively modified): procurement, storage, sale/dispensing. Poisons and substances hazardous to health. Expired medicines, failures, imperfect. Veterinary medicinal products. REV. Homeopathic medicines. Medical devices. Biocide. L. 69/2009. Cosmetic products. Food in pharmacy: HACCP. Oxygen. Protection of intellectual property. Generics. Biosimilars. Orphan drugs. Compassionate use. Off label.
PART 2 - Propaedeutic lectures and practical laboratory exercises. Galenic preparations: preparation of magistral galenic formulations (suppositories, ovules, syrups, solutions, emulsions, suspensions, creams, ointments, gels, pastes). Composition of the price according to the National Price List of drugs, labeling, and control of the preparation. Production of officinal galenic preparations: semi-solid preparations for cutaneous application. Perfusion solutions of the pharmaceutical factories and the Hospital Pharmacy. Preparation of isosmotic and isotonic solutions. Quality control tests: control of the dosage forms (in particular solid dosage forms such as capsules and tablets, and semi-solid preparations) according to the Pharmacopoeia requirements. Composition of the certificate of analysis. Small-scale production of the most common cosmetics. Use of software for the management of professional activity.

PART 1 - To achieve knowledge and skills corresponding to the minimum level of sufficiency, the student is asked to demonstrate knowledge of the topics presented in class. The student is asked to demonstrate that they are able to apply the knowledge acquired relating to the different prescriptions for human and veterinary use, understanding the importance of the different dispensing methods. The student must demonstrate that he has understood the importance of the pharmacy, services and dispensing of medicines, considering the Italian and EU legislation. Furthermore, the individual must have acquired the regulatory knowledge required for the quality control and placing on the market of industrially manufactured medicinal products. The student must demonstrate mastery of appropriate language and the use of precise terminology.
PART 2 - The student must be able to apply the theoretical knowledge acquired in Pharmaceutical Technology and Legislation courses and transfer them in a critical way to technological-pharmaceutical problems. In particular, he/she will have to demonstrate knowledge and explain with adequate scientific language the chemical-physical and technological properties of the excipients and the dosage forms intended for the different routes of administration. In addition, the knowledge related to the plants for the industrial production of pharmaceutical forms will have to be acquired. The student must also have learned the regulatory skills required for the preparation and dispensing of galenics in pharmacies and for the production, quality control and marketing of industrial medicines.