PHARMACEUTICAL LEGISLATION
Learning outcomes of the course unit
Pharmaceutical Regulations will provide an in-depth knowledge of the pharmaceutical legislation concerning, in particular, the practice of community pharmacists who directly provide the essential pharmaceutical service to the citizens or the pharmacist who works in contexts indirectly related to the pharmaceutical service.
Course contents summary
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.
Course contents
International regulations
Italian Healthcare system
Classification of pharmacies and distribution on the territory
Ethics of the pharmacist
Continuing Medical Education (CME)
Standards for the production and trade of medicinal products for human
Classification of medicines
Pharmacopoeias
Discipline dispensing the medicines to the public
Medicinal products not subject to medical prescription
Rules for Veterinary Medicinal Products
Rules interesting medical devices, in vitro diagnostic, biocides and sanitary
Pharmacovigilance
Recommended readings
M. MARCHETTI, P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Ottava Ed. (2015)
FARMACOPEA UFFICIALE ITALIANA XII ed., Istituto Poligrafico dello Stato; Farmacopea Europea.
Teaching methods
Lectures with the aid of computer tools for the projection of lessons. Lessons as well as relevant texts from regulatory agencies and opinion papers are made available to the students.
Assessment methods and criteria
As a further opportunity of evaluation, 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.
