Learning objectives
Upon successful completion of the module of Pharmacy Legislation the student will acquire the knowledge related to the norms regulating the Pharmacy profession.
In particular, the students will have to:
1) know and understand the legislation that regulate the Pharmacy profession and the dispensing of medicinal products (Knowledge and understanding);
2) apply the knowledge to identify the specificities and to apply the correct procedures to fulfil the most common medical prescriptions (Applying knowledge and understanding);
3) being able to integrate new national and European legislation with the acquired knowledge (Learning skills).
Upon successful completion of the module of Pharmaceutical Manufacturing the student will acquire the knowledge related to organization, manufacturing and quality in the pharmacelutical industry.
In particular, the students will have to:
1) know and understand the organization and basic requirements for the manufacturing of medicinal products with specific emphasis on GMP (Knowledge and understanding);
2) know an understand some of the common processes used for the manufacturing of traditional dosage forms (Applying knowledge and understanding);
3) being able to apply the knowledge and independently evaluate which are the regulatory requests in terms of quality, efficacy and safety for traditional and advanced medicinal product (Applying knowledge and understanding).
Prerequisites
Students are required to take the exam of Pharmaceutical Technology
before presenting themselves to the exam of Medicinal Products Manufacturing.
Course unit content
The subject is organized in two separate Modules: the course of Pharmacy Legislation and the course of Pharmaceutical Manufacturing.
The module of Pharmaceutical Legislation has the aim to provide an overview of the regulations related to the pharmacy practice and medicinal product dispensing. The module is divided in three sections.
The first section of the subject is devoted to general presentations related to European regulations, Italian Healthcare system and Health professions registries.
The second part of the subject is dedicated to the administrative classification of pharmacies, public selection for the allocation of new pharmacies, informal and formal substitution of pharmacy owner, temporary administration, professional ethics of the pharmacist, continuing Medical Education (CME).
The final section of the subject is dealing with required standards for the production and trade of human medicinal products, classification of medicinal products, pharmacopoeias, dispensing of medicinal products subject to prescription to the public, medicinal products not subject to medical prescription, regulations specific for veterinary medicinal products, regulations for medical devices and for the food products sold in the pharmacy.
The second part of the subject is dedicated to the administrative classification of pharmacies, public selection for the allocation of new pharmacies, informal and formal substitution of pharmacy owner, temporary administration, professional ethics of the pharmacist, continuing Medical Education (CME).
The final section of the subject is dealing with required standards for the production and trade of human medicinal products, classification of medicinal products, pharmacopoeias, dispensing of medicinal products subject to prescription to the public, medicinal products not subject to medical prescription, regulations specific for veterinary medicinal products, regulations for medical devices.
The module of Pharmaceutical Manufacturing is offering to the students the knowledge related to the main regulation related to the manufacturing of medicinal products and directed to make available to the public medicines with the highest standard of quality, safety and efficacy. In order to achieve this goal the course will provide the basic concepts on the modern manufacturing approaches for the production of medicinal products starting from intellectual property protection, addressing Good Manufacturing Practices (GMPs) and Quality-by-Design and providing practical examples related to the manufacture of a number of dosage forms.
Full programme
Pharmaceutical Legislation
Italian Healthcare system
Classification of pharmacies and distribution on the territory
Pharmacy practice and Services in the Pharmacy, including vaccination.
Standards for the production and trade of human medicinal products (Marketing Authorization, Manufacturing Authorization)
Pharmacovigilance
Classification of medicines
Discipline dispensing the medicines to the public and dispensing of controlled substances.
Medicinal products not subject to medical prescription
Regulations for Veterinary Medicinal Products
Regulations for medical devices, in vitro diagnostics, biocides
Regulations related to cosmetics, food products and alcohols.
Pharmaceutical Manufacturing
- Intellectual Property Protection in the pharmaceutical field
- Structure and organization of pharmaceutical plants
- Good manufacturing practices (GMP)
- Validation
- Water for pharmaceutical productions
- Drying and Lyophilization
- Mixing of liquids
- Mixing of powders
- Filtration
- Milling
- Tabletting
- Capsules Manufacturing
- Manufacturing of sterile dosage forms
- Manufacturing of films
- Manufacturing of pMDI and DPI
- Manufacturing of radiopharmaceuticals
- Manufacturing of biopharmaceutical products
- Manufacturing of medicinal products for gene therapy
- Packaging of medicinal products
Bibliography
Pharmaceutical Legislation
M. MARCHETTI, P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Nona Ed. (2018)
M. CINI, P. RAMPINELLI “Principi di Legislazione Farmaceutica”, Edizioni Minerva Medica, II Ed. (2019)
N. LOLISCIO “La Farmacia: un campo minato. Il manuale del Farmacista” Società Editrice Esculapio (2023)
Pharmaceutical Manufacturing
L. FABRIS A. RIGAMONTI “La Fabbricazione Industriale Dei Medicinali” Societa’ Editrice Esculapio, Ed 2008
P. COLOMBO, P.L. CATTELLANI, A. GAZZANIGA, E. MENEGATTI, E. VIDALE "Principi di Tecnologie Farmaceutiche", 2° Ed. Casa Editrice Ambrosiana (2015).Slides presented during classes will be available every week on Elly portal (http://elly.saf.unipr.it).
Teaching methods
Teaching is delivered via a series of lectures integrated with scientific papers, documents and online materials useful for the understanding and enrichment of the subject discussed in class (uploaded on the Elly website).
All slides are made available online at the Elly website where videorecordings of lectures will be available for a limited time (7 days).
Students will be constantly reminded the appropriate technical language, exposed to real-life profession examples, invited to understand the underlying connections between different parts of the course and other subjects and will be stimulated to actively participate to the lectures with interactive discussions.
Assessment methods and criteria
For both the modules to students attending the lesson is proposed an evaluation of the semester learning through written test at the end of the teaching of each module. The test consists in multiple choice questionnaire.
In alternative an evaluation via oral examination is also possible at the exam sessions.
Other information
Attendance to the lectures is compulsory (minimum 75% of the lectures). Working students are eligible for a reduction of the attendance requirements if officially registered.
Students with SLD/SEND should contact the Centro Accoglienza e Inclusione (http://cai.unipr.it) or the Department reference person (Prof.ssa Franca Zanardi
franca.zanardi@unipr.it - tel. +39 0521 905067)
