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 produts (Knowledge and understanding);
2) apply the knowledge to identify the specificities and to apply the correct procedures to fullfill 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).
3) Understand and evaluate the regulatory requirements (quality, efficacy, safety) of most common ad advanced dosage forms (Applying knowledge and understanding).
Prerequisites
Students are required to take the exam of Pharmaceutical Technology
before sitting the exam of Pharmaceuticals 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 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 REGULATIONS
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 supplements and alcohols.
PHARMACEUTICAL MANUFACTURING
Structure and organization of pharmaceutical plants
Good manufacturing practice
Validation
Freeze Drying
Milling/Micronization
Capsules Manufacturing
Manufacturing of inhaled medicinal products (nebulization, pMDI, DPI) – Prof. Carsten Ehrhardt, TCD, Ireland
Manufacturing of sterile dosage forms
Manufacturing of radiopharmaceuticals
Manufacturing of biological/biotecnological products
Manufacturing of avanced therapy products
Packaging
Bibliography
Legislazione Farmaceutica
M. MARCHETTI, P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Decima Ed. (2021)
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 (2021)
Fabbricazione Industriale dei medicinali
L. FABRIS A. RIGAMONTI “La Fabbricazione Industriale Dei Medicinali” Societa’ Editrice Esculapio, Ed 2008
P.Colombo, F.Alhaique, C.Caramella, B.Conti, A.Gazzaniga, E.Vidale
"Principi Di Tecnologie Farmaceutiche" Seconda Edizione.
Casa Editrice Ambrosiana, 2015
Slides presented during classes will be available every week on Elly portal
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.
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 students attending the module, an evaluation of their learning progression through a written test (30 MCQ, online, 60 minutes time) is offered at the end of the Module lectures. The test is generally delivered in presence, but it can be carried out online if restrictions related to the pandemic will be present.
The results of the test will constitute the basis for the final exam evaluation where the oral exam will be a discussion of test results.
For students not taking the tests or not satisfied with the test results the final exam will be an in depth oral exam (3 questions on Parmaceutical Regulations and 3 questions on Medicinal Products Manufacturing) in presence or online according to the student preference.
Students can register online for the exam using portal ESSE3 (https://unipr.esse3.cineca.it/Home.do) in the sessions available on the official exams calendar of the Dipartimento di Scienze degli Alimenti e del Farmaco.
Exams results are announced at the end of the oral exam and are availale online at ESSE3 portal (https://unipr.esse3.cineca.it/Home.do) within one week from the exam date.
Other information
Attendance to the lectures is compulsory (minimum 75% of the lectures).
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)
