This course is aimed at acquiring the regulatory aspects that govern the activity of manufactory, distribution and dispensing of the drug. Jointly, notions, regarding pharmacy regulation and the profession of the pharmacist, are provided. The course is also aimed at the knowledge of the main methods of analisys applied to decision-making process for the economic evaluation of drug and the characteristic of the pharmaceutical products market.

MEDICINAL REGULATIONS

PHARMACOECONOMICS

Bridging courses are not required.

D1 - KNOWLEDGE AND UNDERSTANDING

At the end of this training activity, the student must demonstrate that he is able to:

1. know the general aspects of law;

2. know the operating bases of the National Health Service and of other institutional, national and supranational bodies related to health and pharmaceuticals;

3. know the general content of the Official Pharmacopoeia and other official texts

4. know the Italian and European authorization process for the production and marketing of the drug;

5. know the legislation relating to the preparation, management and dispensing of human and veterinary drugs in pharmacies;

6. know the rules governing the "pharmacy system";

7. know the economic aspects of drugs;

8. know some aspects of pharmaceutical marketing.

D2- ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING

At the end of this training activity, the student must demonstrate that he is able to:

1. move correctly in the sector of pharmaceutical legislation, putting the various rules in the hierarchy of sources in an appropriate manner;

2. understand the theoretical and practical importance of the various institutions related to the world of drugs;

3. identify the path that each type of medicine may have done, from its conception to its marketing;

4. know how to manage, in essential lines, the pharmacy, from a regulatory-professional point of view, with particular attention to the correct management of prescriptions of drugs for human use, veterinary drugs, narcotic drugs;

5. understand the reasons for many economic choices inherent in the world of drugs and pharmacies.

D3-AUTONOMY OF JUDGMENT

At the end of the course, the student must be able to know the main aspects of the legal system, with particular attention to the regulatory system of the drug. The student must be able to know the main regulations affecting the pharmacy, in order to be able to correctly manage, albeit in essential lines, the professional sphere. The student will also have to demonstrate knowledge and evaluation of the economic aspect of the drug market, through the main types of pharmacoeconomic analysis.

D-4 COMMUNICATION SKILLS

The student, at the end of course, must be able to descript the notions imparted and to espress with appropriate terminology.

D-5 LEARNING ABILITY

At the term of training activity, the student must be able to find, to evaluate and place correctly the new regulations or notions.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

The lessons may be support by professionals of law or professional sector.

Teaching

Frontal teaching.

Attendance

Nobody.

Course books

Main study text:

Casettari-Barberini: Legislazione farmaceutica nella pratica professionale. Piccin ed., 2021;

Supplementary texts, for some aspects:

Frongia-Casettari: Il galenista ed il laboratorio. Edra ed., 2019;

Fabrizio Gianfrate: Farmacoeconomia-La valutazione economica dei farmaci. Edra, 2015.

Reference books:

Paola Minghetti: Legislazione farmaceutica. Cea, 2018;

Nicoletta Lo Liscio: La farmacia. Un campo minato. Il manuale del farmacista, Soc. ed. Esculapio, 2020.

Giuseppe F. Ferrari, Fausto Massimino: Diritto del farmaco. Cacucci ed., 2015;

Tony Ellery, Neal Hansen: Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand. John Wiley & Sons, 2012.

Assessment

The assessment of knowledge includes an oral exam of mean duration of half an hour. The legislative knowledge concerning the industry, the drug as well as the activity of the pharmaceutical service at the community pharmacy will be investigated. The exam includes some pharmacoeconomics questions.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

Attendance

Nodody.

Course books

As for attending students,

Assessment

As for attending students.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.