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84927 - Pharmaceutical Legislation and Pharmacoeconomics

Academic Year 2021/2022

                
                        Docente:
                        Maurizio Cini
                    
                        Credits:
                        6
                    
                        SSD:
                        CHIM/09
                    
                        Language:
                        Italian
                    
                        Teaching Mode:
                        Traditional lectures
                        
                            Campus:
                            Bologna
                        
                            Corso:
                            Single cycle degree programme (LMCU) in
                            Pharmacy (cod. 9219)

                            Teaching resources on Virtuale

Learning outcomes

At the end of the course the student - possesses the specific knowledge to adapt their professional behavior, both for the exercise in pharmacies open to the public and in hospitals as well as in the Pharmaceutical Industry; - knows the discipline of medicines in relation to their preparation, both galenic and industrial, in compliance with the Norms of Good Preparation of Medicines in Pharmacy (NBP) and Good Manufacturing Practices (GMP); - acquires the knowledge of regulations concerning sectors related to medicines such as cosmetics and nutraceuticals; acquires, in addition, familiarity with the principles that govern socio-political choices in health care with particular reference to pharmaceutical spending.

Translated with www.DeepL.com/Translator (free version)

Course contents

REGULATION OF MEDICINAL PRODUCTS AND PHARMACOECONOMICS

Regulation of medicinal products

Elements of law - Italian health organization - Health professions - Professional responsibilities - Articulation of the pharmaceutical service - The profession of pharmacist - Production and distribution of medicines - Regulatory bodies on medicines (FDA, EMA, AIFA) and reciprocity agreements - Package leaflet and Summary of Product Characteristics - Advertising of medicines (to the public and to health professionals) - Non-medicinal products with health value.

Pharmacoeconomics

Principles and concepts of pharmacoeconomics - Health care systems in relation to economic sustainability - Characteristics of the health care market in Italy and in the EU countries - Cost-effectiveness and cost-benefit analysis - Direct, indirect and fixed costs - Pharmaceutical expenditure in Italy (hospital and territorial) - Pharmaceutical distribution in Italy (direct, on account, by agreement).

Readings/Bibliography

Maurizio Cini - Patrizia Rampinelli

Principi di Legislazione Farmaceutica

Edizioni Minerva Medica

Teaching methods

Theoretical lessons in presence and/or on-line

Assessment methods

Oral Examination

Teaching tools

Provision of slides at the same time as the lectures are held

Office hours

See the website of Maurizio Cini